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Evaluate Analgesic Efficacy of Fast Release Aspirin

NCT01117636 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2018-12-19

No results posted yet for this study

Summary

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.

Conditions

  • Drugs, Investigational

Interventions

DRUG

Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Single oral dose of fast release aspirin tablets 1000 mg (2 x 500 mg) with a full glass of water (240 milliliter \[mL\]) between 14 hours post dental surgery.

DRUG

Acetylsalicylic Acid (Aspirin, BAYE4465)

Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 14 hours post dental surgery.

DRUG

Placebo

Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 14 hours post dental surgery.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-28
Primary Completion
2010-07-07
Completion
2010-07-07

Countries

  • United States

Study Locations

More Related Trials

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 NCT01117636 on ClinicalTrials.gov