check_circleStudy Completed

Pain

Safety Trial of Naproxen Sodium/ Diphenhydramine

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

12 - N/A

Trial summary

Enrollment Goal
326
Trial Dates
May 2011 - July 2011
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aleve PM (BAY98-7111)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Rancho Cucamonga Clinical Trials, Inc.Rancho Cucamonga, 91730, United States
Completed
FPA Clinical ResearchKissimmee, 34741, United States
Completed
East Valley Family Physicians, PLCChandler, 85224, United States
Completed
Mesa Family Medical CenterMesa, 85203, United States
Completed
Omega Medical ResearchWarwick, 02886, United States
Completed
Centennial Medical GroupElkridge, 21075, United States
Terminated
Benchmark ResearchSan Angelo, 76904, United States
Completed
Benchmark ResearchMetairie, 70006, United States
Completed
Miami Research AssociatesSouth Miami, 33143, United States
Completed
Integra Clinical Research, LLCSan Antonio, 78231, United States
Completed
Benchmark ResearchSacramento, 95816, United States
Completed
Clinical Research AtlantaStockbridge, 30281, United States
Completed
Benchmark ResearchFort Worth, 76135, United States
Completed
Colorado Springs Health Partners, PCColorado Springs, 80922, United States
Completed
Coastal Carolina Research CenterMt. Pleasant, 29464, United States
Completed
Premier Research GroupPeoria, 85381, United States
Completed
Lifetree Clinical ResearchSalt Lake City, 84106, United States
Completed
Advanced Clinical Research InstituteAnaheim, 92801, United States
Completed
Pines Clinical ResearchPembroke Pines, 33028, United States

Primary Outcome

  • Percentage of subjects with any adverse event for those subjects who were randomized and took at least one dose of investigational product
    date_rangeTime Frame:
    10 days after randomization
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of subjects with any serious adverse event for those subjects who were randomized and took at least one dose of investigational product
    date_rangeTime Frame:
    10 days after randomization
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2