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Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092703
First received: September 23, 2004
Last updated: April 6, 2017
Last verified: April 2017
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Purpose
The purpose of this study is to compare the gastrointestinal tolerability of an investigational drug to an approved drug in the treatment of osteoarthritis during one year treatment period.
| Condition | Intervention | Phase |
|---|---|---|
| Osteoarthritis | Drug: MK0663, etoricoxib Drug: Comparator: Diclofenac sodium | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 50 mg t.i.d. in Patients With Osteoarthritis |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Discontinuations due to clinical and laboratory gastrointestinal adverse experiences during a 1 year treatment period.
| Estimated Enrollment: | 6000 |
| Actual Study Start Date: | June 27, 2002 |
| Study Completion Date: | November 1, 2003 |
| Primary Completion Date: | November 1, 2003 (Final data collection date for primary outcome measure) |
The duration of treatment is 12 months.
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Osteoarthritis of the knee, hip, hand or spine which requires the use of medications for pain relief
Exclusion Criteria:
- Known allergies to the study drugs
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092703
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092703
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Publications:
Study Data/Documents: CSR Synopsis
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00092703 History of Changes |
| Other Study ID Numbers: |
0663-061 2004_052 |
| Study First Received: | September 23, 2004 |
| Last Updated: | April 6, 2017 |
Keywords provided by Merck Sharp & Dohme Corp.:
|
Arcoxia |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Etoricoxib Diclofenac Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 28, 2017