A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea

NCT03448536 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 197372017-005031-17
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to compare the maximum single dose of Aleve® (two tablets, equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength (two caplets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain associated with primary dysmenorrhea.

Conditions

Dysmenorrhea

Keywords

Primary dysmenorrhea of at least moderate severity

Outcome Measures

Primary Outcomes (1)

• Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours

  Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 46. Higher scores was indicative of more pain relief.

  Up to 12 hours post-dose

Secondary Outcomes (9)

• Summed Pain Intensity Difference (SPID) Over 0-12 Hours

  Up to 12 hours post-dose

• SPID Over 0-6 Hours

  Up to 6 hours post-dose

• SPID Over 6-12 Hours

  From 6 hours to 12 hours post-dose

• TOTPAR Over 0-6 Hours

  Up to 6 hours post-dose

• TOTPAR 6-12 Hours

  From 6 hours to 12 hours post-dose

Study Arms (2)

Naproxen Sodium : Acetaminophen

EXPERIMENTAL

Subjects received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2

Drug: Naproxen Sodium, (Aleve, BAY117031); Drug: Acetaminophen (Tylenol Extra Strength)

Acetaminophen : Naproxen Sodium

EXPERIMENTAL

Subjects received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2

Drug: Naproxen Sodium, (Aleve, BAY117031); Drug: Acetaminophen (Tylenol Extra Strength)

Interventions

Naproxen Sodium, (Aleve, BAY117031) DRUG

220 mg \*2 tablets, orally, single dose

Acetaminophen : Naproxen Sodium; Naproxen Sodium : Acetaminophen

Acetaminophen (Tylenol Extra Strength) DRUG

500 mg \*2 caplets, orally, single dose

Acetaminophen : Naproxen Sodium; Naproxen Sodium : Acetaminophen

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ambulatory healthy female patients between 15 and 35 years of age;
• Patient has a history of Over-the-Counter (OTC) analgesic use for treatment of primary dysmenorrhea;
• Patient has a history of regular menstrual cycles that typically occurs between every 21 to 35 days;
• Patient has a self-reported history of primary dysmenorrhea (onset \<5 years after menarche) with at least moderate menstrual cramp pain (based on the categorical pain intensity scale, 0-3) occurring during four of the past six menstrual cycles;
• Patient has a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded;
• Patient typically requires at least one dose of an OTC analgesic medication such as naproxen, aspirin, acetaminophen, or ibuprofen taken on at least 1 day of her menstrual cycle for the treatment of moderate or severe menstrual cramp, and normally experiences pain relief from these medications;
• Patient is of child-bearing potential and is using one of the following methods of contraception and agrees to continue this same method for the duration of the study:
• Abstinence for at least the last 60 days AND willingness to use double barrier method should the patient become sexually active during the study;
• Double barrier method (condom with contraceptive foam, diaphragm with contraceptive gel);
• Permanent sterilization of patient or her spouse/partner;
• Oral contraceptive (must have been using the same oral contraceptive for at least three months prior to study entry and agrees to remain on the same type and method throughout the course of the study).
• Patient is willing to participate in the study and return to the study site within approximately 1 week after her menstrual cycle to return the study medication, urine pregnancy test, and for review of the completed patient e-diary;
• Patient is willing to abstain from alcohol consumption throughout the 12-hour Treatment Period;
• Patient is willing to abstain from caffeine consumption throughout the 12-hour Treatment Period;
• Patient is willing to ingest the overencapsulated tablets throughout the study;

You may not qualify if:

• Patient has a known history of allergic, idiosyncratic or serious adverse reaction, to acetaminophen, naproxen, aspirin, ibuprofen, or any other nonsteroidal anti-inflammatory drug (NSAID);
• Patient has a known allergy to any of the excipients in any of the study medication products;
• Patient has experienced asthma, urticaria, or allergic-type reactions after taking aspirin, acetaminophen or other NSAIDs;
• Patient has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the Investigator's judgment, contraindicates administration of the study medication;
• Patient has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration;
• Patient has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection (currently acute or recurrent \[defined as more than three per year\] prior history of an urinary tract infection is eligible for enrollment), adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact patient safety and/or the study data;
• Patient has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge;
• Patient requires prescription analgesics, narcotic, non-NSAID (i.e., defined as oral use of 5 or more times per week for greater than 3 weeks) or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms;
• Patient is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents). Patients who are on a stable dose for at least 3 months, and not taking this medication for dysmenorrhea or premenstrual syndrome are eligible for enrollment;
• Patient does not agree to abstain from taking any analgesic and/or anti-inflammatory medication (with the exception of low dose aspirin \[defined as no greater than 100 mg daily\] taken for cardioprotective purposes) approximately 72 hours prior to the anticipated treatment period and throughout the dosing/assessment period. All pain and anti-inflammatory medications including supplements, topical heat or cold, and other products of topical application will be discontinued approximately 72 hours prior to the anticipated dosing for each treatment period and throughout the dosing/assessment period;
• Patient does not agree to abstain from using transcutaneous electrical nerve stimulation devices that are used to treat dysmenorrhea throughout each treatment period;
• Patient is taking piroxicam (Feldene®) or oral corticosteroids. Patients taking inhaled or topical corticosteroids are eligible for enrollment;
• Patient is pregnant, lactating , or less than 6 months postpartum;
• Patient is currently using an intra-uterine devices (IUD), or using hormonal implants (e.g., Norplant) or injections (e.g., Depo-Provera) for contraception or used within the past 6 months;
• Patient is currently using an oral contraceptive for less than 3 months, has been on a unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months or intends to do so in the course of the study;

Sponsors & Collaborators

• Bayer: lead

Study Sites (8)

Radiant Research, Inc.

Chandler, Arizona, 85224, United States

Location

Radiant Research, Inc.

Scottsdale, Arizona, 85251, United States

Location

Radiant Research, Inc.

Pinellas Park, Florida, 33781, United States

Location

Radiant Research, Inc.

Chicago, Illinois, 60602, United States

Location

Radiant Research, Inc.

Akron, Ohio, 44311, United States

Location

Radiant Research, Inc.

Cincinnati, Ohio, 45236, United States

Location

Radiant Research, Inc.

Dallas, Texas, 75234, United States

Location

Synexus US, LP- Plano

Plano, Texas, 75234, United States

Location

Related Publications (1)

• Daniels SE, Paredes-Diaz A, An R, Centofanti R, Tajaddini A. Significant, long-lasting pain relief in primary dysmenorrhea with low-dose naproxen sodium compared with acetaminophen: a double-blind, randomized, single-dose, crossover study. Curr Med Res Opin. 2019 Dec;35(12):2139-2147. doi: 10.1080/03007995.2019.1654987. Epub 2019 Aug 28.

  PMID: 31397597 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Naproxen; Acetaminophen

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 28, 2018
• Study Start: April 5, 2018
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: October 28, 2019
• Results First Posted: October 28, 2019

Record last verified: 2019-10

Locations

US (8)