A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)

Postoperative Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effects of Rofecoxib 50 mg and Valdecoxib 40 mg in Patients With Postoperative Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092339
• Other study ID #: 0966-190
• Secondary ID: 2004_069
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: May 5, 2017
• Start date: August 1, 2002
• Est. completion date: September 15, 2002

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Description:

The duration of treatment is 1 day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 15, 2002
• Est. primary completion date: September 15, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Impaction of a molar tooth requiring removal

Exclusion Criteria:

• Any known allergy to the study drugs

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Toothache

Intervention

Drug:
• MK0966, rofecoxib

• Comparator: valdecoxib, placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Daniels SE, Desjardins PJ, Bird SR, Smugar SS, Tershakovec AM. Rofecoxib 50 mg and valdecoxib 20 or 40 mg in adults and adolescents with postoperative pain after third molar extraction: results of two randomized, double-blind, placebo-controlled, single-dose studies. Clin Ther. 2006 Jul;28(7):1022-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall analgesic effect as measured by total pain relief over 12 hours.
Secondary	Overall analgesic effect over 8 hrs.
Secondary	Time to onset of analgesic, peak analgesic and duration of analgesic effects.
Secondary	Percent of patients using and amount used of supplemental analgesia within 8, 12, and 24 hrs.
Secondary	Overall safety and tolerability.