Study of Acetaminophen (ACM) in Post-operative Dental Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post Operative Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test acetaminophen

acetaminophen tablet and placebo caplet and placebo liquid-filled capsule

Group Type EXPERIMENTAL

acetaminophen Tablet

Intervention Type DRUG

2 test acetaminophen 500 mg tablets

Placebo Caplet

Intervention Type DRUG

2 placebo caplets

Placebo Liquid-filled capsule

Intervention Type DRUG

2 placebo Liquid-filled capsules

Commercial acetaminophen

acetaminophen caplet and placebo tablet and placebo liquid-filled capsule

Group Type ACTIVE_COMPARATOR

acetaminophen Caplet

Intervention Type DRUG

2 commercial acetaminophen 500 mg caplets

Placebo Tablet

Intervention Type DRUG

2 placebo tablets

Placebo Liquid-filled capsule

Intervention Type DRUG

2 placebo Liquid-filled capsules

Commercial ibuprofen

ibuprofen liquid-filled capsule and placebo tablet and placebo caplet

Group Type ACTIVE_COMPARATOR

ibuprofen Liquid-filled capsule

Intervention Type DRUG

2 commercial ibuprofen 200 mg Liquid-filled capsules

Placebo Tablet

Intervention Type DRUG

2 placebo tablets

Placebo Caplet

Intervention Type DRUG

2 placebo caplets

Placebo

Placebo tablet and placebo caplet and placebo liquid-filled capsule

Group Type PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type DRUG

2 placebo tablets

Placebo Caplet

Intervention Type DRUG

2 placebo caplets

Placebo Liquid-filled capsule

Intervention Type DRUG

2 placebo Liquid-filled capsules

Interventions

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acetaminophen Tablet

2 test acetaminophen 500 mg tablets

Intervention Type DRUG

acetaminophen Caplet

2 commercial acetaminophen 500 mg caplets

Intervention Type DRUG

ibuprofen Liquid-filled capsule

2 commercial ibuprofen 200 mg Liquid-filled capsules

Intervention Type DRUG

Placebo Tablet

2 placebo tablets

Intervention Type DRUG

Placebo Caplet

2 placebo caplets

Intervention Type DRUG

Placebo Liquid-filled capsule

2 placebo Liquid-filled capsules

Intervention Type DRUG

Other Intervention Names

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Test ACM Commercial ACM Commercial IBU

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No