Study of Acetaminophen (ACE) in Post-operative Dental Pain
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 17 - 50 |
| Updated: | 1/19/2017 |
| Start Date: | December 2014 |
| End Date: | April 2015 |
A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Proof of Concept Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
This is a dental pain study evaluating the efficacy and safety of a single dose of test
acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen
(IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of
three or four third molars.
acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen
(IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of
three or four third molars.
Inclusion Criteria:
1. Are 17 to 50 years of age
2. Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
3. Dental extraction of three or four third-molars.
4. Experience moderate to severe pain after extraction of third molars
Exclusion Criteria:
1. Currently pregnant (or planning to be pregnant) or nursing a baby
2. Known allergy to acetaminophen (ACE) or non-steroidal anti-inflammatory drugs
(NSAIDs)
3. Inability to swallow whole large tablets or capsules
4. Have other conditions that the investigator feels may impact subject's safety and/or
the integrity of the study
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