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

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ClinicalTrials.gov Identifier: NCT00631111
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : August 10, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: effervescent ibuprofen tablets Drug: effervescent Aspirin plus Vitamin C tablets Drug: ibuprofen tablets Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II
Study Start Date : November 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: effervescent ibuprofen tablets
Active Comparator: 2 Drug: effervescent Aspirin plus Vitamin C tablets
Active Comparator: 3 Drug: ibuprofen tablets
Placebo Comparator: 4 Drug: placebo



Primary Outcome Measures :
  1. Sum of pain relief and pain intensity difference scores [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. Time to meaningful pain relief [ Time Frame: 8 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631111


Locations
United States, Texas
Austin, Texas, United States, 78705
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00631111     History of Changes
Other Study ID Numbers: AI-07-02
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: August 10, 2009
Last Verified: July 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
dental pain
analgesic
NSAID
ibuprofen
aspirin

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aspirin
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics