- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00631111
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
July 10, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
270
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78705
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 38 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
|
Active Comparator: 2
|
|
Placebo Comparator: 4
|
|
Active Comparator: 3
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sum of pain relief and pain intensity difference scores
Time Frame: 8 hours
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to meaningful pain relief
Time Frame: 8 hours
|
8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
February 28, 2008
First Submitted That Met QC Criteria
February 28, 2008
First Posted (Estimate)
March 7, 2008
Study Record Updates
Last Update Posted (Estimate)
August 10, 2009
Last Update Submitted That Met QC Criteria
July 10, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Tooth Diseases
- Facial Pain
- Toothache
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Aspirin
- Ibuprofen
- Ascorbic Acid
Other Study ID Numbers
- AI-07-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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