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

Wyeth

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: ibuprofen tablets

Drug: effervescent Aspirin plus Vitamin C tablets

Drug: placebo

Drug: effervescent ibuprofen tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00631111

AI-07-02

Details and patient eligibility

About

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.

Enrollment

270 patients

Sex

All

Ages

16 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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