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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Ascorbic Acid; Aspirin; Ibuprofen

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