check_circleStudy Completed
Pain
Bayer Identifier:
15560
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
BothAge
12 - N/ATrial summary
Enrollment Goal
326Trial Dates
May 2011 - July 2011Phase
Phase 3Could I Receive a placebo
YesProducts
Aleve PM (BAY98-7111)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Rancho Cucamonga Clinical Trials, Inc. | Rancho Cucamonga, 91730, United States |
Completed | FPA Clinical Research | Kissimmee, 34741, United States |
Completed | East Valley Family Physicians, PLC | Chandler, 85224, United States |
Completed | Mesa Family Medical Center | Mesa, 85203, United States |
Completed | Omega Medical Research | Warwick, 02886, United States |
Completed | Centennial Medical Group | Elkridge, 21075, United States |
Terminated | Benchmark Research | San Angelo, 76904, United States |
Completed | Benchmark Research | Metairie, 70006, United States |
Completed | Miami Research Associates | South Miami, 33143, United States |
Completed | Integra Clinical Research, LLC | San Antonio, 78231, United States |
Completed | Benchmark Research | Sacramento, 95816, United States |
Completed | Clinical Research Atlanta | Stockbridge, 30281, United States |
Completed | Benchmark Research | Fort Worth, 76135, United States |
Completed | Colorado Springs Health Partners, PC | Colorado Springs, 80922, United States |
Completed | Coastal Carolina Research Center | Mt. Pleasant, 29464, United States |
Completed | Premier Research Group | Peoria, 85381, United States |
Completed | Lifetree Clinical Research | Salt Lake City, 84106, United States |
Completed | Advanced Clinical Research Institute | Anaheim, 92801, United States |
Completed | Pines Clinical Research | Pembroke 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 productdate_rangeTime Frame:10 days after randomizationenhanced_encryptionYesSafety Issue:
- Percentage of subjects with any serious adverse event for those subjects who were randomized and took at least one dose of investigational productdate_rangeTime Frame:10 days after randomizationenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2