Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and Celecoxib

Pain Clinical Trial

Official title:

A Randomized, Double-blind, Double-dummy, Parallel Group, Single-center Study Evaluating the Analgesic Effect of Single Doses of Lumiracoxib 400 mg, Celecoxib 400 mg and Placebo in the Treatment of Post-dental Surgery Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348491
• Other study ID #: CCOX189A2474
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2006
• Last updated: February 21, 2017
• Start date: February 2006

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. primary completion date: May 2006
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Requiring extraction of two or more partially impacted or fully bony impacted third molars. At least one of the extractions must be mandibular

• Moderate to severe post-dental surgery pain intensity (as rated by the patient on the categorical pain intensity scale within five hours of surgery

Exclusion Criteria:

• Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lumiracoxib

Locations

Country	Name	City	State
United States	Dental Research Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fricke J, Davis N, Yu V, Krammer G. Lumiracoxib 400 mg compared with celecoxib 400 mg and placebo for treating pain following dental surgery: a randomized, controlled trial. J Pain. 2008 Jan;9(1):20-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superiority of a single dose of lumiracoxib 400 mg compared to placebo and celecoxib 400 mg based on a Summed (time weighted) Pain Intensity Difference calculated over 0-8 hours post-dose (SPID-8)
Secondary	Evaluate efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to celecoxib 400 mg in relieving post dental surgery pain with respect to the following secondary efficacy variables:
Secondary	Time-specific Pain intensity Difference (PID) based on the categorical scale, Pain Relief (PR) based on the categorical scale, and Pain Relief Intensity Difference (PRID) (sum of PID and PR based on categorical scales) at time-points up to 24 hours after
Secondary	Time-specific PID based on VAS at time-points up to 24 hours after dosing

External Links

•   Results for CCOX189A2474 from the Novartis Clinical Trials website