check_circleStudy Completed

Sleep

Evaluate analgesic/sedative efficacy of Naproxen sodium and diphenhydramine

Trial purpose

The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination

Key Participants Requirements

Sex

Both

Age

16 - 45 Years

Trial summary

Enrollment Goal
162
Trial Dates
January 2008 - February 2008
Phase
Phase 4
Could I Receive a placebo
No
Products
Aleve PM (BAY98-7111)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Jean Brown ResearchSalt Lake City, 84124, United States

Primary Outcome

  • Total sleep time measured by actigraphy
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Wake 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
  • Global assessment of study medication 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
  • Total sleep time by subject assessment
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Sleep quality index
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Overall rating of severity in categorical pain rating scale score
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in categorical pain rating scale score
    date_rangeTime Frame:
    Baseline and up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Overall rating of severity in visual analog scale (VAS) score
    date_rangeTime Frame:
    At 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in visual analog scale (VAS) score
    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 participants taking rescue medication by hour
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Global assessment of study medication as a pain reliever
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Number of times participants took rescue medication
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Total wake 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
  • Activity mean measured by actigraphy
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No
  • Wake episode measured by actigraphy
    date_rangeTime Frame:
    Up to 10 hours
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6