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Safety Trial of Naproxen Sodium/ Diphenhydramine (MUST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01365052
First received: May 17, 2011
Last updated: May 16, 2014
Last verified: May 2014

May 17, 2011
May 16, 2014
May 2011
July 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Please see further details in AE section
  • Incidence of adverse events by body system and preferred term [ Time Frame: After 10 days ] [ Designated as safety issue: Yes ]
  • The proportion 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: After 10 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01365052 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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 ] [ Designated as safety issue: Yes ]
  • Treatment Compliance - Number of Capsules Taken [ Time Frame: 10 days after randomization ] [ Designated as safety issue: No ]
  • Treatment Compliance - Duration of Exposure to Treatment in Days [ Time Frame: 10 days after randomization ] [ Designated as safety issue: No ]
Not Provided
 
Safety Trial of Naproxen Sodium/ Diphenhydramine
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Pain
  • 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
  • Drug: Placebo
    2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
  • Experimental: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
    Intervention: Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
July 2011
July 2011   (final data collection date for primary outcome measure)

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)
Both
12 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01365052
15560
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP