NCT01117636

Evaluate Analgesic Efficacy of Fast Release Aspirin

A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 1000 mg in Postsurgical Dental Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-04-28
• Primary completion: 2010-07-07
• Completion: 2010-07-07
• First posted: 2010-05-05
• Last updated: 2018-12-19

Locations

2 sites across 1 country: United States