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

Last updated: July 10, 2009
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Overall Status: Completed

Phase

3

Condition

Pain

Oral Facial Pain

Acute Pain

Treatment

N/A

Clinical Study ID

NCT00631111
AI-07-02
  • Ages 16-40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 270
Study Start date:
November 01, 2007
Estimated Completion Date:
April 30, 2008

Connect with a study center

  • Austin, Texas 78705
    United States

    Site Not Available

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