check_circleStudy Completed
Pain, postoperative
Bayer Identifier:
14837
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Evaluate analgesic/sedative efficacy of Naproxen sodium and diphenhydramine in patients with Postsurgical Dental Pain
Trial purpose
The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.
Key Participants Requirements
Sex
BothAge
12 - 45 YearsTrial summary
Enrollment Goal
712Trial Dates
October 2010 - February 2011Phase
Phase 3Could I Receive a placebo
NoProducts
Aleve PM (BAY98-7111)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Pharmaceutical Product Development, LLC | Austin, 78744, United States |
Completed | Jean Brown Research | Salt Lake City, 84124, United States |
Primary Outcome
- Wake time after sleep onset (WASO) measured by actigraphydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Sleep latency measured by actigraphydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Total sleep time measured by actigraphydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Sleep efficiency measured by actigraphydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Global assessment of investigational product as a sleep aiddate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - sleep qualitydate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - calmness of sleepdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - easiness to fall asleepdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - premature awakeningdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - ease of awakeningdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - well resteddate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Karolinska sleep diary - sufficient sleepdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Subjective sleep questionnaire - quality of your sleep last nightdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Subjective sleep questionnaire - refreshing nature of your sleep last nightdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Subjective sleep questionnaire - time to fall asleep last nightdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Subjective sleep questionnaire - number of minutes you think that you were awake from the time you fell asleep until the time you got out of beddate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Change from baseline in pain intensitydate_rangeTime Frame:Baseline and up to 10 hoursenhanced_encryptionNoSafety Issue:
- Overall rating of pain reliefdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Time to rescue medicationdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Cumulative proportion of subjects taking rescue medication by hourdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
- Global assessment of investigational product as a pain relieverdate_rangeTime Frame:Up to 10 hoursenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4