Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: effervescent ibuprofen tablets
• Drug: effervescent Aspirin plus Vitamin C tablets
• Drug: ibuprofen tablets
• Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
• Active Comparator: 3
• Placebo Comparator: 4

Primary Measures

• Sum of pain relief and pain intensity difference scores
  • Time Frame: 8 hours
    Safety Issue?: No

Secondary Measures

• Time to meaningful pain relief
  • Time Frame: 8 hours
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00631111

Study ID Number: AI-07-02

ClinicalTrials.gov Identifier: NCT00631111

Health Authority: United States: Food and Drug Administration