Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain

This study has been completed.

First Received: February 28, 2008 Last Updated: July 10, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00631111

Purpose

Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.

Condition	Intervention	Phase
Pain	Drug: effervescent ibuprofen tablets Drug: effervescent Aspirin plus Vitamin C tablets Drug: ibuprofen tablets Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Ibuprofen

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Sum of pain relief and pain intensity difference scores [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to meaningful pain relief [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Enrollment:	270
Study Start Date:	November 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: effervescent ibuprofen tablets
2: Active Comparator	Drug: effervescent Aspirin plus Vitamin C tablets
3: Active Comparator	Drug: ibuprofen tablets
4: Placebo Comparator	Drug: placebo

Eligibility

Ages Eligible for Study:	16 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion:

Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone)
Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide

Exclusion:

Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function)
Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation
Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631111

Locations

United States, Texas

Austin, Texas, United States, 78705

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	AI-07-02
Study First Received:	February 28, 2008
Last Updated:	July 10, 2009
ClinicalTrials.gov Identifier:	NCT00631111 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

dental pain
analgesic
NSAID
ibuprofen
aspirin

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Tooth Diseases
Molecular Mechanisms of Pharmacological Action
Toothache
Physiological Effects of Drugs
Hematologic Agents
Pain
Fibrinolytic Agents
Signs and Symptoms
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Ibuprofen
Facial Pain
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Stomatognathic Diseases
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010