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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-01-31

Brief Summary

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The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.

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Detailed Description

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This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ACE-1000

1000 mg Acetaminophen Caplet

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Acetaminophen Caplet - single dose

ACE-650

650 mg Acetaminophen Caplet

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Acetaminophen Caplet - single dose

ACE-0

0 mg Acetaminophen Caplet

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type DRUG

0 mg Caplet - single dose

Interventions

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Acetaminophen

Acetaminophen Caplet - single dose

Intervention Type DRUG

Placebo Control

0 mg Caplet - single dose

Intervention Type DRUG

Other Intervention Names

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Tylenol Control

Eligibility Criteria

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Inclusion Criteria

* Must be at least 16 and less than 51 years of age
* Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
* Must have up to four of their back teeth (third-molars) pulled

Exclusion Criteria

* Cannot be allergic to acetaminophen (Tylenol)
* Cannot be pregnant (or planning to be pregnant) or nursing a baby
* Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No