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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: effervescent ibuprofen tablets; Drug: effervescent Aspirin plus Vitamin C tablets; Drug: ibuprofen tablets; Drug: placebo

• Registration Number: NCT00631111
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-03-07
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-07
• Disposition First Submitted: 2009-07-10
• Disposition First Submitted QC: 2009-07-10
• Last Update Submitted: 2009-07-10
• Disposition First Posted: 2009-08-10
• Last Update Posted: 2009-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	effervescent ibuprofen tablets	-
2	effervescent Aspirin plus Vitamin C tablets	-
3	ibuprofen tablets	-
4	placebo	-

Primary Outcome Measures

Name	Time	Method
Sum of pain relief and pain intensity difference scores	8 hours

Secondary Outcome Measures

Name	Time	Method
Time to meaningful pain relief	8 hours