check_circleStudy Completed

Toothache

Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.

Trial purpose

To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.

Key Participants Requirements

Sex

Both

Age

16 - 45 Years

Trial summary

Enrollment Goal
312
Trial Dates
June 2008 - August 2008
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Jean Brown ResearchSalt Lake City, 84124, United States
Completed
Pharmaceutical Product Development, LLCAustin, 78744, United States
Completed
SCIREX-Premier Clinical ResearchAustin, 78705, United States

Primary Outcome

  • Summed Pain Intensity Difference (SPID)
    date_rangeTime Frame:
    0 to 24 hours post dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Total Pain Relief (TOTPAR)
    date_rangeTime Frame:
    0-24 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Summed Pain Intensity Difference at Specific Time Intervals
    date_rangeTime Frame:
    0-16 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Time to First Use of Rescue Medication
    date_rangeTime Frame:
    postdose to first use of rescue medication
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    Safety Issue:
    No
  • Global Assessment of the Investigational Product as a Pain Reliever
    date_rangeTime Frame:
    at 24 hours postdose or immediately before first use of rescue medication
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    Safety Issue:
    No
  • Time to Onset of Effect
    date_rangeTime Frame:
    from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Dental Pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2