check_circleStudy Completed

Pain, postoperative

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

Both

Age

12 - 45 Years

Trial summary

Enrollment Goal
712
Trial Dates
October 2010 - February 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
Aleve PM (BAY98-7111)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Pharmaceutical Product Development, LLCAustin, 78744, United States
Completed
Jean Brown ResearchSalt Lake City, 84124, United States

Primary Outcome

  • Wake time after sleep onset (WASO) measured by actigraphy
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Sleep latency measured by actigraphy
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Total sleep time measured by actigraphy
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Sleep efficiency measured by actigraphy
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Global assessment of investigational product as a sleep aid
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Karolinska sleep diary - sleep quality
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Karolinska sleep diary - calmness of sleep
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Karolinska sleep diary - easiness to fall asleep
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Karolinska sleep diary - premature awakening
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Karolinska sleep diary - ease of awakening
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Karolinska sleep diary - well rested
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Karolinska sleep diary - sufficient sleep
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Subjective sleep questionnaire - quality of your sleep last night
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Subjective sleep questionnaire - refreshing nature of your sleep last night
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Subjective sleep questionnaire - time to fall asleep last night
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • 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 bed
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in pain intensity
    date_rangeTime Frame:
    Baseline and up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Overall rating of pain relief
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Time to rescue medication
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Cumulative proportion of subjects taking rescue medication by hour
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Global assessment of investigational product as a pain reliever
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain with Phase Advanced Sleep
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4