NCT01115673

To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. · Industry
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.

Detailed description

This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen	Acetaminophen Caplet - single dose
DRUG	Placebo Control	0 mg Caplet - single dose

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-05-04
• Last updated: 2012-05-28
• Results posted: 2012-05-28

Locations

1 site across 1 country: United States