Study of Acetaminophen (ACM) in Post-operative Dental Pain
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 17 - 50 |
| Updated: | 12/20/2017 |
| Start Date: | April 30, 2016 |
| End Date: | October 5, 2016 |
A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of
1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial
products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400
mg following third molar (wisdom tooth) extraction.
1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial
products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400
mg following third molar (wisdom tooth) extraction.
This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active
controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety
profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour
period after third-molar extractions. Subjects will undergo dental extraction of three or
four third molars.
controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety
profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour
period after third-molar extractions. Subjects will undergo dental extraction of three or
four third molars.
Inclusion Criteria:
1. 17 years to 50 years old
2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
3. Dental extraction of three or four molars
4. Experience moderate to severe pain after extraction of third molars
5. Females of childbearing age must be willing to use acceptable method of birth control
Exclusion Criteria:
1. Currently pregnant or planning to be pregnant or nursing a baby
2. Known allergy to acetaminophen (ACM) 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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