- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00348491
Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and Celecoxib
February 21, 2017 updated by: Novartis Pharmaceuticals
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
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.
Study Overview
Study Type
Interventional
Enrollment
364
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Austin, Texas, United States, 78703
- Dental Research Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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)
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Secondary Outcome Measures
Outcome Measure |
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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:
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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
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Time-specific PID based on VAS at time-points up to 24 hours after dosing
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
July 3, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Lumiracoxib
Other Study ID Numbers
- CCOX189A2474
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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