check_circleStudy Completed

Drugs, Investigational

Evaluate analgesic efficacy of fast release Aspirin

Trial purpose

The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 650 mg (2 x 325 mg) compared to regular aspirin tablets, 650 mg (2 x 325 mg) and placebo in subjects with postsurgical dental pain.

Key Participants Requirements

Sex

Both

Age

16 - 45 Years

Trial summary

Enrollment Goal
500
Trial Dates
April 2010 - August 2010
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Salt Lake City, 84124, United States
Completed
Austin, 78705, United States

Primary Outcome

  • Time to First Perceptible Pain Relief (PR)
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    Safety Issue:
    No
  • Time to First Perceptible Pain Relief Confirmed
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time to meaningful pain relief
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    Safety Issue:
    No
  • Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
    date_rangeTime Frame:
    10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
    date_rangeTime Frame:
    10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
    date_rangeTime Frame:
    10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6
    date_rangeTime Frame:
    0 - 6 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6
    date_rangeTime Frame:
    0-6 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Time to First use of Rescue Medication
    date_rangeTime Frame:
    0 to 6 hours
    enhanced_encryption
    Safety Issue:
    No
  • Cumulative Percentage of Subjects Taking Rescue Medication
    date_rangeTime Frame:
    1, 2, 3, 4, 5, and 6 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication
    date_rangeTime Frame:
    At 6 hours postdose or immediately before first use of rescue medication
    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 a Fast Release Aspirin 650 mg in Postsurgical Dental Pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3