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Evaluate Onset of Action of a Fast Release Aspirin

NCT01420094 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2018-12-19

No results posted yet for this study

Summary

To compare the safety and efficacy (onset, duration of relief and overall efficacy) of a single dose of a fast release formulation of aspirin 1000 mg compared to acetaminophen 1000 mg and placebo for relief of pain following extraction of impacted third molars.

Conditions

  • Healthy Subjects

Interventions

DRUG

Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Single oral dose of fast release aspirin tablet 1000 mg (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 milliliter \[mL\]) between 1-4 hours post dental surgery.

DRUG

Acetaminophen (Tylenol extra strength)

Single oral dose of acetaminophen (Tylenol extra strength) caplet 1000 mg (2 x 500 mg) and 2 placebo matching aspirin tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery.

DRUG

Placebo

Single oral dose of placebo (2 placebo aspirin tablets and 2 placebo acetaminophen caplets) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-16
Primary Completion
2011-09-08
Completion
2011-09-08

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01420094 on ClinicalTrials.gov