check_circleStudy Completed
Drugs, Investigational
Bayer Identifier:
15120
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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, 1000 mg (2 x 500 mg) compared to regular aspirin tablets, 1000 mg (2 x 500 mg) and placebo in subjects with postsurgical dental pain.
Key Participants Requirements
Sex
BothAge
16 - 45 YearsTrial summary
Enrollment Goal
514Trial Dates
April 2010 - July 2010Phase
Phase 3Could I Receive a placebo
YesProducts
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Austin, 78744, United States | |
Completed | Salt Lake City, 84106, United States |
Primary Outcome
- Time to First Perceptible Pain Relief (PR)date_rangeTime Frame:0 to 6 hoursenhanced_encryptionnoSafety Issue:
- Time to First Perceptible Pain Relief (PR) Confirmeddate_rangeTime Frame:0 to 6 hoursenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Time to Meaningful Pain Relief (PR)date_rangeTime Frame:0 to 6 hoursenhanced_encryptionnoSafety Issue:
- Pain Intensity at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After DosingPain Intensity (PI) was rated by subjects on a 4-point Categorical Pain Intensity Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose.date_rangeTime Frame:10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours postdoseenhanced_encryptionnoSafety Issue:
- Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After DosingPain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose. For each post-dose time point, PID was derived by subtracting the pain intensity at the post-dose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement.date_rangeTime Frame:10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdoseenhanced_encryptionnoSafety Issue:
- Pain Relief at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After DosingPain relief was rated by subjects using a 5-point Categorical Relief Rating Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).date_rangeTime Frame:10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdoseenhanced_encryptionNoSafety Issue:
- Summed Pain Intensity Differences (SPID) From Hour 0 Through Hour 2, Hour 4 and Hour 6date_rangeTime Frame:0 to 6 hours postdoseenhanced_encryptionNoSafety Issue:
- Summed Total Pain Relief (TOTPAR) From Hour 0 Through Hour 2, Hour 4 and Hour 6date_rangeTime Frame:0-6 hours post-doseenhanced_encryptionNoSafety Issue:
- Time to First use of Rescue Medicationdate_rangeTime Frame:0 to 6 hoursenhanced_encryptionNoSafety Issue:
- Cumulative Percentage of Subjects Taking Rescue Medicationdate_rangeTime Frame:1, 2, 3, 4, 5, and 6 hours postdoseenhanced_encryptionNoSafety Issue:
- Global Assessment of the Investigational Product as a Pain Reliever at 6 Hours After Dosing or Immediately Before the First Intake of Rescue Medicationdate_rangeTime Frame:At 6 hours postdose or immediately before first use of rescue medicationenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
3Additional Information
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