Safety Trial of Naproxen Sodium/ Diphenhydramine (MUST)
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ClinicalTrials.gov Identifier: NCT01365052 |
Recruitment Status :
Completed
First Posted : June 3, 2011
Results First Posted : June 16, 2014
Last Update Posted : June 8, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 326 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111) |
Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
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 |
Placebo Comparator: Placebo |
Drug: Placebo
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days |
- Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product [ Time Frame: 10 days after randomization ]Please see further details in Adverse Events (AE) section
- Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product [ Time Frame: 10 days after randomization ]Please see further details in AE section
- 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 [ Time Frame: 10 days after randomization ]
- Treatment Compliance - Number of Capsules Taken [ Time Frame: 10 days after randomization ]
- Treatment Compliance - Duration of Exposure to Treatment in Days [ Time Frame: 10 days after randomization ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365052
United States, Arizona | |
Chandler, Arizona, United States, 85224 | |
Mesa, Arizona, United States, 85203 | |
Peoria, Arizona, United States, 85381 | |
United States, California | |
Anaheim, California, United States, 92801 | |
Rancho Cucamonga, California, United States, 91730 | |
Sacramento, California, United States, 95816 | |
United States, Colorado | |
Colorado Springs, Colorado, United States, 80922 | |
United States, Florida | |
Kissimmee, Florida, United States, 34741 | |
Pembroke Pines, Florida, United States, 33028 | |
South Miami, Florida, United States, 33143 | |
United States, Georgia | |
Stockbridge, Georgia, United States, 30281 | |
United States, Louisiana | |
Metairie, Louisiana, United States, 70006 | |
United States, Maryland | |
Elkridge, Maryland, United States, 21075 | |
United States, Rhode Island | |
Warwick, Rhode Island, United States, 02886 | |
United States, South Carolina | |
Mt. Pleasant, South Carolina, United States, 29464 | |
United States, Texas | |
Fort Worth, Texas, United States, 76135 | |
San Angelo, Texas, United States, 76904 | |
San Antonio, Texas, United States, 78231 | |
United States, Utah | |
Salt Lake City, Utah, United States, 84106 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT01365052 |
Other Study ID Numbers: |
15560 |
First Posted: | June 3, 2011 Key Record Dates |
Results First Posted: | June 16, 2014 |
Last Update Posted: | June 8, 2015 |
Last Verified: | May 2015 |
Maximum Use Safety Trial |
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