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

McNeil-PPC

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Placebo Control; Drug: Acetaminophen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01115673

ACEPAI2001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 540 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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540 participants in 3 patient groups, including a placebo group

ACE-1000

Experimental group

Description:

1000 mg Acetaminophen Caplet

Treatment:

Drug: Acetaminophen

ACE-650

Active Comparator group

Description:

650 mg Acetaminophen Caplet

Treatment:

Drug: Acetaminophen

ACE-0

Placebo Comparator group

Description:

0 mg Acetaminophen Caplet

Treatment:

Drug: Placebo Control