Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma

NCT02139644 | Completed Phase 3 Results

• 2 other identifiers: FSS-AS-3012014-001149-25
• Study Type: interventional
• Target: 787
• Locations: 8 countries
• Sites: 140

Brief Summary

The primary objective of this study was to evaluate the efficacy of fluticasone propionate multidose dry powder inhaler (Fp MDPI) and fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (FS MDPI) when administered over 12 weeks in patients 12 years of age and older with persistent asthma. Study drug and placebo was supplied in Teva multidose dry powder inhaler (MDPI) devices and provided for participants to use at home. Participants performed spirometry at every visit. Each participant was given a diary at each visit for use until the next visit. Rescue medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by the investigational center personnel.

Conditions

Asthma

Keywords

fluticasone propionate; multidose dry powder inhaler

Outcome Measures

Primary Outcomes (2)

• Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12

  A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Data from these assessments were used to analyze the primary endpoint of baseline adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement. The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value.

  Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours

• Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12

  Trough FEV1 was a morning spirometry taken predose and pre-rescue bronchodilator. If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled. The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1).

  Day 1 (predose, baseline), Week 12

Secondary Outcomes (7)

• Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment

  Days -6 to Day 1 (predose), Day 1 (postdose) daily until Week 12

• Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period

  Days -6 to Day 1 (predose, baseline) to Week 12

• Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period

  Days -6 to Day 1 (predose, baseline), up to week 12

• Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12

  up to Week 12 of the Treatment Period

• Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old

  Day 1 (predose, baseline), end of trial (up to week 12)

Study Arms (5)

FS MDPI 100 / 12.5 mcg

EXPERIMENTAL

Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Drug: FS MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate

FS MDPI 50 / 12.5 mcg

EXPERIMENTAL

Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Drug: FS MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate

Fp MDPI 100 mcg

EXPERIMENTAL

Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg for a total daily dose of 200 mcg for 12 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Drug: Fp MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate

Fp MDPI 50 mcg

EXPERIMENTAL

Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg for a total daily dose of 100 mcg for 12 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Drug: Fp MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate

Placebo MDPI

PLACEBO COMPARATOR

The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart). Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Drug: Placebo MDPI; Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate

Interventions

FS MDPI DRUG

FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to either 100/12.5 mcg Fp/Sx or 50/12.5 mcg Fp/Sx in the morning and evening for a total daily dose of 200/25 mcg or 100/25 mcg Fp/Sx. Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Also known as: fluticasone propionate, inhaled corticosteroid, salmeterol xinafoate, β2 adrenoceptor agonist

FS MDPI 100 / 12.5 mcg; FS MDPI 50 / 12.5 mcg

Fp MDPI DRUG

Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to either 100 mcg or 50 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 100 mcg. Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Also known as: fluticasone propionate, inhaled corticosteroid

Fp MDPI 100 mcg; Fp MDPI 50 mcg

Placebo MDPI DRUG

Placebo administered via a multidose dry powder inhaler (MDPI) one puff in the morning and one puff in the evening for 12 weeks.

Also known as: inert powder

Placebo MDPI

albuterol/salbutamol DRUG

A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).

Also known as: short-acting β2-adrenergic agonists

FS MDPI 100 / 12.5 mcg; FS MDPI 50 / 12.5 mcg; Fp MDPI 100 mcg; Fp MDPI 50 mcg; Placebo MDPI

Beclomethasone dipropionate DRUG

QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate. Patients took 1 puff twice a day from open-label QVAR 40 mcg hydrofluoroalkane (specifically, HFA-134a) metered-dose inhaler (MDI) for the duration of the Run-in Period (14-21 days) and prior to randomization. A clinically equivalent dose of inhaled corticosteroid (ICS) was substituted in countries where QVAR 40 mcg was not available.

Also known as: QVAR

FS MDPI 100 / 12.5 mcg; FS MDPI 50 / 12.5 mcg; Fp MDPI 100 mcg; Fp MDPI 50 mcg; Placebo MDPI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Best pre-bronchodilator forced expiratory volume in 1 second (FEV1) of 40 to 85% of their predicted normal value.
• Current Asthma Therapy: Patients must have a short-acting β2-agonist (for rescue use) for a minimum of 8 weeks before the Screening Visit (SV) and a low-dose inhaled corticosteroid (ICS). The low-dose ICS may be either as ICS monotherapy or as an ICS/long-acting beta agonist (LABA) combination. The ICS component of the patient's asthma therapy should be stable for a minimum of 1 months before providing consent.
• Reversibility of Disease: Patients must have at least 15% reversibility (all patients) and at least a 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol at the SV. Note: Patients who do not qualify for the study due to failure to meet reversibility will be permitted to perform a retest once within 7 days.
• Patients must provide written informed consent/assent. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written assent form must be signed and dated by the patient (if applicable). Note: Age requirements are as specified by local regulations.
• Outpatient \>= 12 years of age on the date of consent/assent. In countries where the local regulations permit enrollment of adult patients only, patients must be 18 years of age and older.
• Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institutes of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days.
• The patient is able to perform acceptable and repeatable spirometry.
• The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter.
• The patient is able to use a MDI device without a spacer device and a MDPI device.
• The patient is able to withhold (as judged by the investigator) his or her regimen of ICS or study drug, and rescue medication for at least 6 hours before the SV and before all treatment visits.
• The patient/parent/legal guardian/caregiver is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements.
• SABAs: All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol for the duration of the study.
• Female patients may not be pregnant, breastfeeding, or attempting to become pregnant.
• other criteria may apply, please contact the investigator for more information

You may not qualify if:

• A history of a life-threatening asthma exacerbation (an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures).
• The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study.
• The patient has participated as a randomized patient in any investigational drug study within 30 days of the SV.
• The patient has previously participated as a randomized patient in a study of Fp MDPI or FS MDPI.
• The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug or rescue medication formulation (ie, lactose).
• The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days before the SV.
• The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV.
• The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient must not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
• The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV.
• The patient has a history of alcohol or drug abuse within 2 years preceding the SV.
• The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV.
• The patient has used immunosuppressive medications within 4 weeks before the SV.
• The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications.
• The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
• The patient has a history of a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (140)

Teva Investigational Site 12397

Birmingham, Alabama, United States

Location

Teva Investigational Site 12375

Glendale, Arizona, United States

Location

Teva Investigational Site 12395

Cypress, California, United States

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Teva Investigational Site 12476

Encinitas, California, United States

Location

Teva Investigational Site 12586

Fountain Valley, California, United States

Location

Teva Investigational Site 12591

Fresno, California, United States

Location

Teva Investigational Site 12372

Huntington Beach, California, United States

Location

Teva Investigational Site 12365

Los Angeles, California, United States

Location

Teva Investigational Site 12381

Los Angeles, California, United States

Location

Teva Investigational Site 12401

Los Angeles, California, United States

Location

Teva Investigational Site 12394

Mission Viejo, California, United States

Location

Teva Investigational Site 12490

Rancho Mirage, California, United States

Location

Teva Investigational Site 12393

Riverside, California, United States

Location

Teva Investigational Site 12366

Rolling Hills Estates, California, United States

Location

Teva Investigational Site 12383

San Diego, California, United States

Location

Teva Investigational Site 12370

San Jose, California, United States

Location

Teva Investigational Site 12371

Stockton, California, United States

Location

Teva Investigational Site 12579

Upland, California, United States

Location

Teva Investigational Site 12379

Centennial, Colorado, United States

Location

Teva Investigational Site 12386

Centennial, Colorado, United States

Location

Teva Investigational Site 12596

Colorado Springs, Colorado, United States

Location

Teva Investigational Site 12584

Longmont, Colorado, United States

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Teva Investigational Site 12484

Waterbury, Connecticut, United States

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Teva Investigational Site 12590

Waterbury, Connecticut, United States

Location

Teva Investigational Site 12493

Clearwater, Florida, United States

Location

Teva Investigational Site 12992

Largo, Florida, United States

Location

Teva Investigational Site 12376

Miami, Florida, United States

Location

Teva Investigational Site 12390

Miami, Florida, United States

Location

Teva Investigational Site 12583

Orlando, Florida, United States

Location

Teva Investigational Site 12481

Tallahassee, Florida, United States

Location

Teva Investigational Site 12491

Winter Park, Florida, United States

Location

Teva Investigational Site 12997

Decatur, Georgia, United States

Location

Teva Investigational Site 12392

Savannah, Georgia, United States

Location

Teva Investigational Site 12592

Shiloh, Illinois, United States

Location

Teva Investigational Site 12483

Lenexa, Kansas, United States

Location

Teva Investigational Site 12399

Baltimore, Maryland, United States

Location

Teva Investigational Site 12391

Bethesda, Maryland, United States

Location

Teva Investigational Site 12589

Columbia, Maryland, United States

Location

Teva Investigational Site 12369

Rockville, Maryland, United States

Location

Teva Investigational Site 12396

Fall River, Massachusetts, United States

Location

Teva Investigational Site 12384

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 12585

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 12588

Ypsilanti, Michigan, United States

Location

Teva Investigational Site 12494

St Louis, Missouri, United States

Location

Teva Investigational Site 12595

St Louis, Missouri, United States

Location

Teva Investigational Site 12594

Missoula, Montana, United States

Location

Teva Investigational Site 12385

Ocean City, New Jersey, United States

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Teva Investigational Site 12380

Skillman, New Jersey, United States

Location

Teva Investigational Site 12587

Brooklyn, New York, United States

Location

Teva Investigational Site 12485

Rockville Centre, New York, United States

Location

Teva Investigational Site 12475

Huntersville, North Carolina, United States

Location

Teva Investigational Site 12364

Raleigh, North Carolina, United States

Location

Teva Investigational Site 12374

Canton, Ohio, United States

Location

Teva Investigational Site 12480

Cincinnati, Ohio, United States

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Teva Investigational Site 12492

Cincinnati, Ohio, United States

Location

Teva Investigational Site 12487

Middleburg Heights, Ohio, United States

Location

Teva Investigational Site 12488

Sylvania, Ohio, United States

Location

Teva Investigational Site 12377

Edmond, Oklahoma, United States

Location

Teva Investigational Site 12368

Medford, Oregon, United States

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Teva Investigational Site 12382

Portland, Oregon, United States

Location

Teva Investigational Site 12400

Pittsburgh, Pennsylvania, United States

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Teva Investigational Site 12473

Upland, Pennsylvania, United States

Location

Teva Investigational Site 12389

Greenville, South Carolina, United States

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Teva Investigational Site 12580

Mt. Pleasant, South Carolina, United States

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Teva Investigational Site 12398

Orangeburg, South Carolina, United States

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Teva Investigational Site 12991

Knoxville, Tennessee, United States

Location

Teva Investigational Site 12990

Cypress, Texas, United States

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Teva Investigational Site 12373

Dallas, Texas, United States

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Teva Investigational Site 12402

El Paso, Texas, United States

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Teva Investigational Site 12582

New Braunfels, Texas, United States

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Teva Investigational Site 12363

San Antonio, Texas, United States

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Teva Investigational Site 12482

San Antonio, Texas, United States

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Teva Investigational Site 12477

Waco, Texas, United States

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Teva Investigational Site 12478

Murray, Utah, United States

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Teva Investigational Site 12388

South Burlington, Vermont, United States

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Teva Investigational Site 12378

Milwaukee, Wisconsin, United States

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Teva Investigational Site 11065

Toronto, Ontario, Canada

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Teva Investigational Site 11067

Montreal, Quebec, Canada

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Teva Investigational Site 11068

Vancouver, Quebec, Canada

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Teva Investigational Site 54084

Neratovice, Czechia

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Teva Investigational Site 54088

Prague, Czechia

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Teva Investigational Site 54087

Rokycany, Czechia

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Teva Investigational Site 51134

Budapest, Hungary

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Teva Investigational Site 51143

Budapest, Hungary

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Teva Investigational Site 51144

Budapest, Hungary

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Teva Investigational Site 51140

Debrecen, Hungary

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Teva Investigational Site 51142

Deszk, Hungary

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Teva Investigational Site 51165

Dombóvár, Hungary

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Teva Investigational Site 51145

Kiskunhalas, Hungary

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Teva Investigational Site 51141

Miskolc, Hungary

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Teva Investigational Site 51133

Mosdós, Hungary

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Teva Investigational Site 51136

Nyíregyháza, Hungary

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Teva Investigational Site 51139

Nyíregyháza, Hungary

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Teva Investigational Site 51163

Sopron, Hungary

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Teva Investigational Site 51137

Szeged, Hungary

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Teva Investigational Site 51164

Szigetvár, Hungary

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Teva Investigational Site 51138

Szombathely, Hungary

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Teva Investigational Site 53182

Bialystok, Poland

Location

Teva Investigational Site 53183

Bialystok, Poland

Location

Teva Investigational Site 53185

Bialystok, Poland

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Teva Investigational Site 53191

Bialystok, Poland

Location

Teva Investigational Site 53187

Bienkówka, Poland

Location

Teva Investigational Site 53219

Bydgoszcz, Poland

Location

Teva Investigational Site 53217

Dębica, Poland

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Teva Investigational Site 53178

Krakow, Poland

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Teva Investigational Site 53180

Krakow, Poland

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Teva Investigational Site 53188

Krakow, Poland

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Teva Investigational Site 53220

Lodz, Poland

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Teva Investigational Site 53235

Lodz, Poland

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Teva Investigational Site 53221

Lódz, Poland

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Teva Investigational Site 53237

Lublin, Poland

Location

Teva Investigational Site 53194

Poznan, Poland

Location

Teva Investigational Site 53234

Poznan, Poland

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Teva Investigational Site 53233

Strzelce Opolskie, Poland

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Teva Investigational Site 53179

Tarnów, Poland

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Teva Investigational Site 53218

Tarnów, Poland

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Teva Investigational Site 53193

Warsaw, Poland

Location

Teva Investigational Site 53181

Wroclaw, Poland

Location

Teva Investigational Site 53189

Wroclaw, Poland

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Teva Investigational Site 50236

Chelyabinsk, Russia

Location

Teva Investigational Site 50227

Kazan', Russia

Location

Teva Investigational Site 50234

Moscow, Russia

Location

Teva Investigational Site 50238

Moscow, Russia

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Teva Investigational Site 50230

Novosibirsk, Russia

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Teva Investigational Site 50224

Saint Petersburg, Russia

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Teva Investigational Site 50231

Saint Petersburg, Russia

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Teva Investigational Site 50233

Voronezh, Russia

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Teva Investigational Site 50237

Yaroslavl, Russia

Location

Teva Investigational Site 50226

Yekaterinburg, Russia

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Teva Investigational Site 90002

Cape Town, South Africa

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Teva Investigational Site 90008

Cape Town, South Africa

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Teva Investigational Site 90005

Centurion, South Africa

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Teva Investigational Site 90001

Johannesburg, South Africa

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Teva Investigational Site 90003

Middelburg, South Africa

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Teva Investigational Site 90007

Pretoria, South Africa

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Teva Investigational Site 58125

Kharkiv, Ukraine

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Teva Investigational Site 58126

Kharkiv, Ukraine

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Teva Investigational Site 58127

Kyiv, Ukraine

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Teva Investigational Site 58128

Kyiv, Ukraine

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Teva Investigational Site 58129

Vinnytsia, Ukraine

Location

Related Publications (3)

• Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

  PMID: 36472162 DERIVED

• Raphael G, Yiu G, Sakov A, Liu S, Caracta C. Randomized, double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older. J Asthma. 2018 Jun;55(6):640-650. doi: 10.1080/02770903.2017.1350971. Epub 2017 Aug 31.

  PMID: 28763243 DERIVED

• Miller DS, Yiu G, Hellriegel ET, Steinfeld J. Dose-ranging study of salmeterol using a novel fluticasone propionate/salmeterol multidose dry powder inhaler in patients with persistent asthma. Allergy Asthma Proc. 2016 Jul;37(4):291-301. doi: 10.2500/aap.2016.37.3963. Epub 2016 May 27.

  PMID: 27216137 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Salmeterol Xinafoate; Albuterol; Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Chlorinated

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 15, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 12, 2021
• Results First Posted: April 12, 2017

Record last verified: 2021-11

Locations

PL (22); UA (5); RU (10); US (76); CZ (3); CA (3); HU (15); ZA (6)