Safety Trial of Naproxen Sodium/ Diphenhydramine (MUST)

• ClinicalTrials.gov Identifier: NCT01365052
• Recruitment Status: Completed
• First Posted: June 3, 2011
• Results First Posted: June 16, 2014
• Last Update Posted: June 8, 2015
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111); Drug: Placebo	Phase 3

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Other Outcome Measures:

1. 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 ]
2. Treatment Compliance - Number of Capsules Taken [ Time Frame: 10 days after randomization ]
3. Treatment Compliance - Duration of Exposure to Treatment in Days [ Time Frame: 10 days after randomization ]

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01365052
• Other Study ID Numbers: 15560
• First Posted: June 3, 2011
• Results First Posted: June 16, 2014
• Last Update Posted: June 8, 2015
• Last Verified: May 2015

Keywords provided by Bayer:

Maximum Use Safety Trial

Additional relevant MeSH terms:

Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gout Suppressants; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action