Trials / Completed
CompletedNCT01960114
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 403 (actual)
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. · Industry
- Sex
- All
- Age
- 17 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetaminophen ER | Single dose (2 tablets) Acetaminophen ER 750 mg |
| DRUG | Placebo | Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2013-10-10
- Last updated
- 2015-07-10
- Results posted
- 2015-06-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01960114. Inclusion in this directory is not an endorsement.