Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
Information source: Wyeth
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: effervescent ibuprofen tablets (Drug); effervescent Aspirin plus Vitamin C tablets (Drug); ibuprofen tablets (Drug); placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
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.
Clinical Details
Official title: Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Sum of pain relief and pain intensity difference scores
Secondary outcome: Time to meaningful pain relief
Eligibility
Minimum age: 16 Years.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Austin, Texas 78705, United States; Recruiting
Additional Information
Starting date: November 2007
Ending date: April 2008
Last updated: February 28, 2008
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