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

NCT ID: NCT02320708

Last Updated: 2021-12-03

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

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Pain

Keywords

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Molar,third; Teeth,wisdom; Pain, Postoperative; Dental Surgery; Third molar extraction

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 (ACE) (1000 mg) and placebo

Group Type EXPERIMENTAL

Acetaminophen (ACE) (1000 mg)

Intervention Type DRUG

2 Test ACE 500 mg tablets taken orally one time

Placebo

Intervention Type DRUG

2 placebo caplets for acetaminophen taken orally one time

Placebo

Intervention Type DRUG

2 placebo soft-gels for ibuprofen taken orally one time

Commerical ACE (1000 mg) and placebo

Group Type ACTIVE_COMPARATOR

Commercial ACE (1000 mg)

Intervention Type DRUG

2 ACE 500 mg caplets taken orally one time

Placebo

Intervention Type DRUG

2 placebo soft-gels for ibuprofen taken orally one time

Placebo

Intervention Type DRUG

2 placebo tablets for Test acetaminophen taken orally one time

Commerical Ibuprofen (IBU) (400 mg) and placebo

Group Type ACTIVE_COMPARATOR

Commercial Ibuprofen (IBU) (400 mg)

Intervention Type DRUG

2 IBU 200 mg soft-gels taken orally one time

Placebo

Intervention Type DRUG

2 placebo caplets for acetaminophen taken orally one time

Placebo

Intervention Type DRUG

2 placebo tablets for Test acetaminophen taken orally one time

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 placebo caplets for acetaminophen taken orally one time

Placebo

Intervention Type DRUG

2 placebo soft-gels for ibuprofen taken orally one time

Placebo

Intervention Type DRUG

2 placebo tablets for Test acetaminophen taken orally one time

Interventions

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Acetaminophen (ACE) (1000 mg)

2 Test ACE 500 mg tablets taken orally one time

Intervention Type DRUG

Commercial ACE (1000 mg)

2 ACE 500 mg caplets taken orally one time

Intervention Type DRUG

Commercial Ibuprofen (IBU) (400 mg)

2 IBU 200 mg soft-gels taken orally one time

Intervention Type DRUG

Placebo

2 placebo caplets for acetaminophen taken orally one time

Intervention Type DRUG

Placebo

2 placebo soft-gels for ibuprofen taken orally one time

Intervention Type DRUG

Placebo

2 placebo tablets for Test acetaminophen taken orally one time

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role collaborator

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Locations

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Jean Brown Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CO-140128120904-PACT

Identifier Type: -

Identifier Source: org_study_id