Safety Trial of Naproxen Sodium/ Diphenhydramine
MUST
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population
1 other identifier
interventional
326
1 country
19
Brief Summary
The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pain
Started May 2011
Shorter than P25 for phase_3 pain
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
June 16, 2014
CompletedJune 8, 2015
May 1, 2015
2 months
May 17, 2011
January 24, 2014
May 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
Please see further details in Adverse Events (AE) section
10 days after randomization
Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
Please see further details in AE section
10 days after randomization
Other Outcomes (3)
Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product
10 days after randomization
Treatment Compliance - Number of Capsules Taken
10 days after randomization
Treatment Compliance - Duration of Exposure to Treatment in Days
10 days after randomization
Study Arms (2)
Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
Eligibility Criteria
You may qualify if:
- Healthy, ambulatory, male and female volunteers ages 12 and older
- History of experiencing occasional sleeplessness accompanied by aches and pains at least two times, but not continually for more than 14 days per month, in at least 2 of the past 3 months
- Female subjects of childbearing potential must be using a medically acceptable form of birth control, e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, for at least 1 month prior to screening (3 months on oral contraceptives), or double-barrier and have a negative pregnancy test at Screening. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or have had a hysterectomy and/or bilateral oophorectomy
- Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
- Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects \<18 years of age must sign a written assent and have parental or guardian consent).
You may not qualify if:
- History of hypersensitivity to naproxen sodium, acetaminophen, or any NSAIDs (Nonsteroidal Antiinflammatory Drugs), diphenhydramine or any other antihistamines, and similar pharmacological agents or components of the product
- Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies with the last 5 years
- A history of a chronic or severe sleep problem which does not respond to OTC (Over-the-counter) medication and/or requires a prescription hypnotic or sedative
- Currently experiencing chronic pain or on chronic NSAID therapy (defined as taking a daily \[5 to 7 days per week\] regimen of prescription or OTC NSAIDs)
- Current or past history of gastrointestinal ulcers or bleeding or other bleeding disorders
- Use of any OTC or prescription medications with which the administration of naproxen, acetaminophen, or any NSAIDs, diphenhydramine or any other antihistamines or sedatives, is contraindicated
- Chronic use of other products containing diphenhydramine, including topical products
- Use of steroids or blood thinning (anticoagulant) drugs (aspirin 81 mg is permitted if the dose has been taken for at least one month prior to screening)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (19)
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Mesa, Arizona, 85203, United States
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Rancho Cucamonga, California, 91730, United States
Unknown Facility
Sacramento, California, 95816, United States
Unknown Facility
Colorado Springs, Colorado, 80922, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Pembroke Pines, Florida, 33028, United States
Unknown Facility
South Miami, Florida, 33143, United States
Unknown Facility
Stockbridge, Georgia, 30281, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Elkridge, Maryland, 21075, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Fort Worth, Texas, 76135, United States
Unknown Facility
San Angelo, Texas, 76904, United States
Unknown Facility
San Antonio, Texas, 78231, United States
Unknown Facility
Salt Lake City, Utah, 84106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2011
First Posted
June 3, 2011
Study Start
May 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
June 8, 2015
Results First Posted
June 16, 2014
Record last verified: 2015-05