Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection

NCT01406587 | Completed Phase 2

• 1 other identifier: PP4001.301
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 25

Brief Summary

PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center, randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of symptoms associated with uncomplicated urinary tract infection. After the screening, patients are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data about uncomplicated urinary tract infection symptoms are collected from the subjects on electronic handheld devices throughout the 48-hour study period. The primary endpoint is burning during urination.

Conditions

Urinary Tract Infection

Keywords

Burning; Dysuria; Frequency; Pain; Uncomplicated Urinary Tract Infection; Uncomplicated UTI; Urinary Tract Infection; UTI; Burning during urination associated with uncomplicated urinary tract infection; Urination frequency associated with uncomplicated urinary tract infection; Pain associated with uncomplicated urinary tract infection

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of PP4001 for the relief of burning during urination as measured by the subject's self-reported score at the time of urination in women with uUTI in comparison to placebo.

  Assessed at each urination from the time of randomization to 48 hours post first dose.

Secondary Outcomes (9)

• Change from baseline in the physical exam evaluation at the End of Study visit

  The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit.

• To assess the efficacy of PP4001 for the relief of pain as measured by the subject's self-reported score at the time of urination.

  Assessed at each urination from the time of randomization through 48 hours post first dose.

• To assess the efficacy of PP4001 for reduction in urination frequency as measured by the subject's self-reported void diary.

  Assessed at each urination from the time of randomization through 48 hours post first dose.

• To evaluate the duration of therapeutic response to PP4001 50 mg, 100 mg and 200 mg.

  Efficacy measures assessed in 2-hour windows after each dose.

• To assess global assessment of uUTI symptom severity and change over time as measured by the subject-reported global assessment diaries.

  Assessed at each urination from the time of randomization through 48 hours post first dose.

Study Arms (4)

PP4001 50 mg

EXPERIMENTAL

Drug: PP4001

PP4001 100 mg

EXPERIMENTAL

Drug: PP4001

PP4001 200 mg

EXPERIMENTAL

Drug: PP4001

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PP4001 DRUG

50 mg, 1 dose every 12 hours x 4 doses

PP4001 50 mg

Placebo DRUG

Placebo, 1 dose every 12 hours x 4 doses

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects must be ≥ 18 and ≤ 75 years of age at the time of consent.
• Females not of childbearing potential (FNCBP) are eligible for randomization. FNCBP are defined as postmenopausal women with their last menstrual cycle (without exogenous hormone therapy) completed more than 12 consecutive months before screening or women who are surgically sterilized (hysterectomy, oophorectomy, or tubal ligation). Females of childbearing potential also are eligible for randomization provided they are not pregnant or nursing and employ appropriate methods of contraceptives for the duration of the trial. Medically acceptable forms of contraception include abstinence, oral contraceptives, intra-uterine devices, injectable hormonals, intra-vaginal rings, or double-barrier methods (condom plus spermicide), for at least 1 month prior to treatment. Subjects in a monogamous, long term relationship with a partner who has had a vasectomy at least 3 months prior to screening are also study eligible.
• Diagnosis of uncomplicated UTI as defined by having both of the following:
• Presence of supporting symptoms including new onset (within 1 week) of urination frequency, painful urination, and/or urgency.
• Positive dipstick test for leukocyte esterase.
• Demonstration of moderate to severe burning during urination as measured by a score of at least six (6) on the 11-point rating scale for Burning During Urination during screening.
• A negative urine pregnancy test for women of childbearing potential.
• If subject has a chronic, clinically stable disease that requires medication, medication to treat that disease must be stable for at least 30 days prior to screening.
• Ability to perform study procedures, including the completion of electronic diary assessments, and supply the necessary information to the study personnel as required by the protocol.
• A signed informed consent form in which the subject agrees to participate after the study has been fully explained.

You may not qualify if:

• Clinically significant medical history or a clinically significant abnormal finding on the physical exam, vital signs or ECG at screening, including serious acute illness (e.g. pneumonia), gastrointestinal illness that would interfere with study drug absorption, or an untreated or unstable medical illness that would likely interfere with the study assessments.
• At risk in terms of the precautions, warnings, and contraindications in the package insert for phenazopyridine hydrochloride including:
• Known hypersensitivity to phenazopyridine hydrochloride (Defined by a history of allergic or adverse response to the drug).
• Renal failure or insufficiency (Defined as having a history of abnormal renal function or as having a known renal disease).
• History of hepatic disease or failure (Defined as having known liver disease or having elevated LFTs (\> 2 times the ULN) on previous laboratory testing. Patients who would not otherwise have such testing are not required to undergo special study labs).
• Known G-6-PD (glucose-6-phosphate dehydrogenase) deficiency.
• Prior use of a phenazopyridine product within 6 months of the first dose of study drug and throughout the study.
• Use of any prescription analgesic medication (e.g. opioids, prescription nonsteroidal anti-inflammatory drugs (NSAID), etc.) for urinary tract pain or other pain (headache, back pain, joint pain, dental pain, sore muscles, etc) within one and a half (1.5) dosing intervals for that medication before the firs dose of study drug, and throughout the study.
• Use of any systemic antibiotic within seven (7) days of study participation.
• Subjects with complaint of abnormal vaginal discharge.
• Current diagnosis or suspicion of complicated UTI or systemic infection based on one or more of the following:
• Known presence of an anatomic or functional abnormality.
• Presence of a urinary catheter.
• Infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy.
• Clinical signs of systemic infection such as fever (oral or tympanic temperature \>38 degrees Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting.

Sponsors & Collaborators

• Pinnacle Pharmaceuticals, Inc.: lead

Study Sites (25)

Drug Research and Analysis Corp.

Montgomery, Alabama, 36106, United States

Location

Mesa Family Medical Center/Clincal Research Advantage

Mesa, Arizona, 85203, United States

Location

Desert Clinical Research/Clinical Research Advantage

Mesa, Arizona, 85213, United States

Location

Central Phoenix Medical Clinic/Clinical Research Advantage

Phoenix, Arizona, 85020, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Women's Health Care Research

San Diego, California, 92123, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Urology Center of Central Florida/Triquest Clinical Research Inc.

Saint Cloud, Florida, 34769, United States

Location

Soapstone Center for Clinical Research

Decatur, Georgia, 30034, United States

Location

Hutzel Women's Health Research

Detroit, Michigan, 48201, United States

Location

Bellevue Family Practice/Clinical Research Advantage

Bellevue, Nebraska, 68005, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89123, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Hometown Urgent Care and Research

Groveport, Ohio, 43125, United States

Location

Hometown Urgent Care and Research

Springfield, Ohio, 45504, United States

Location

Ellipsis Research Group, LLC

Columbia, South Carolina, 29201, United States

Location

Palmetto Clinical Research, LLC

Greenville, South Carolina, 29615, United States

Location

InvestiClin Research

Brentwood, Tennessee, 37027, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Paresthesia; Dysuria; Pain

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lower Urinary Tract Symptoms; Urological Manifestations

Study Officials

• Suma Krishnan

  Pinnacle Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: August 1, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

US (25)