Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

664 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2018-04-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain.

NCT00240825

Pain

COMPLETED PHASE4

An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain

NCT00240864

Pain

COMPLETED PHASE4

A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain

NCT02912650

Post-surgical Pain Following Extraction of Molar Teeth

COMPLETED PHASE3

To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery

NCT01115673

Pain

COMPLETED PHASE3

Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain

NCT01559259

Pain

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test ACM 1000 mg compared with two commercial products over a four-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-operative Dental Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Post-operative dental pain following third molar extraction.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test acetaminophen

Test acetaminophen 1000 mg dose

Group Type EXPERIMENTAL

Test acetaminophen

Intervention Type DRUG

single dose of 2 Test acetaminophen 500 mg tablets

Commercial acetaminophen

Commercial acetaminophen 1000 mg dose

Group Type ACTIVE_COMPARATOR

Commercial acetaminophen

Intervention Type DRUG

single dose of 2 acetaminophen 500 mg caplets

Commercial ibuprofen

Commercial ibuprofen, 400 mg dose

Group Type ACTIVE_COMPARATOR

Commercial ibuprofen

Intervention Type DRUG

Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 placebo caplets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Test acetaminophen

single dose of 2 Test acetaminophen 500 mg tablets

Intervention Type DRUG

Commercial acetaminophen

single dose of 2 acetaminophen 500 mg caplets

Intervention Type DRUG

Commercial ibuprofen

Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules

Intervention Type DRUG

Placebo

2 placebo caplets

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Test ACM Commercial ACM Commercial IBU

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 17 to 50 years old
2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)
3. Dental extraction of three or four third molars
4. Meets post-surgical pain criteria
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, nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, as well as hydrocodone or other opioids
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
5. Use of pain medications 5 or more times per week
6. Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the last 5 years
7. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
8. Have a positive urine drug screen

Minimum Eligible Age

17 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No