check_circleStudy Completed

Pain, Postoperative

Evaluate efficacy and safety of extended release (ER) Naproxen Sodium

Trial purpose

The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.

Key Participants Requirements

Sex

Both

Age

15 - N/A

Trial summary

Enrollment Goal
300
Trial Dates
June 2011 - September 2011
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Pharmaceutical Product Development, LLCAustin, 78744, United States

Primary Outcome

  • Summed, Time-weighted Pain Intensity Difference from 0 to 24 hours postdose (SPID0-24)
    date_rangeTime Frame:
    From 0 to 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Summed, time-weighted pain intensity differences (SPID)
    date_rangeTime Frame:
    0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose
    enhanced_encryption
    Safety Issue:
    No
  • Summed, time-weighted total pain relief scores (TOTPARs)
    date_rangeTime Frame:
    0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose
    enhanced_encryption
    Safety Issue:
    No
  • Pain Intensity Differences (PIDs) by time from initial dose
    date_rangeTime Frame:
    At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
    enhanced_encryption
    Safety Issue:
    No
  • Pain Relief from initial dose
    date_rangeTime Frame:
    At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
    enhanced_encryption
    Safety Issue:
    No
  • Time to first intake of rescue medication
    date_rangeTime Frame:
    Up to 24 hours postdose
    enhanced_encryption
    Safety Issue:
    No
  • Cumulative percentage of participants who took rescue medication
    date_rangeTime Frame:
    At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
    enhanced_encryption
    Safety Issue:
    No
  • Number of times the participants took rescue medication over the 24-hour period
    date_rangeTime Frame:
    24 hours postdose
    enhanced_encryption
    Safety Issue:
    No
  • Global assessment of the investigational product as a pain reliever
    date_rangeTime Frame:
    24 hours postdose or immediately before the first intake of rescue medication
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Analgesic Efficacy and Safety of Extended Release Naproxen Sodium Tablets in Postsurgical Dental Pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3