check_circleStudy Completed

Pharyngitis

Evaluate the time of pain relief of fast acting aspirin versus acetaminophen in subjects diagnosed with sore throat pain

Trial purpose

This study is to evaluate the onset of relief provided by a single, oral dose of fast release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat pain.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
177
Trial Dates
September 2011 - April 2012
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Storrs, 06269-2011, United States

Primary Outcome

  • Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale
    date_rangeTime Frame:
    Up to two hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent)
    date_rangeTime Frame:
    Two hours postdose or immediately before the intake of rescue medication
    enhanced_encryption
    Safety Issue:
    No
  • Time to first perceptible relief (defined as the time when the subject presses the first stopwatch)
    date_rangeTime Frame:
    Up to two hours
    enhanced_encryption
    Safety Issue:
    No
  • Time weighted sum of pain intensity differences (PID) scores over first hour
    date_rangeTime Frame:
    Up to one hour
    enhanced_encryption
    Safety Issue:
    No
  • Time weighted sum of pain intensity differences (PID) scores over 2 hours
    date_rangeTime Frame:
    Up to two hours
    enhanced_encryption
    Safety Issue:
    No
  • Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief
    date_rangeTime Frame:
    Up to two hours
    enhanced_encryption
    Safety Issue:
    No

Trial design

Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3