Status:
COMPLETED
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Pain
Eligibility:
All Genders
16-40 years
Phase:
PHASE3
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 ...
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
Exclusion
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00631111
Start Date
November 1 2007
End Date
April 1 2008
Last Update
August 10 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Austin, Texas, United States, 78705