Status:
COMPLETED
An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Pain
Eligibility:
All Genders
15+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the onset of pain relief from a single dose of acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the surgical extractio...
Detailed Description
The primary objective of this randomized, double-blind, placebo-controlled study is to determine the onset of analgesia following the administration of a single dose of 1000 mg of acetaminophen, 400 m...
Eligibility Criteria
Inclusion
- Indicates moderate to severe pain following the extraction of at least three molars (including at least one partial or complete bony mandibular third molar impaction)
- weighs at least 100 pounds and has a Body Mass Index (BMI) between 18 and 28
- not taking any medications for anxiety, depression or schizophrenia
- if female, not pregnant or breastfeeding
Exclusion
- Used ibuprofen or acetaminophen within 12 hours preceding surgery or any other pain relievers or anti-inflammatory drugs within 24 hours preceding surgery
- have any gastrointestinal disease that would interfere with the absorption and excretion of study medications
- unable to swallow the study medication whole
- have any significant medical condition
- have a history of adverse reactions to acetaminophen, ibuprofen or any anesthetic agent used in the extraction
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00240864
End Date
February 1 2004
Last Update
June 19 2015
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