Safety Trial of Naproxen Sodium/ Diphenhydramine (MUST)

Study Description

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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

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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

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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

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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

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Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here and search for drug information provided by the FDA. 

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. 

Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01365052 History of Changes
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; Diphenhydramine; Promethazine; 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	Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Antiemetics; Autonomic Agents; Gastrointestinal Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Hypnotics and Sedatives; Anti-Allergic Agents; Antipruritics; Dermatologic Agents