Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)
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| ClinicalTrials.gov Identifier: NCT00092703 |
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Recruitment Status :
Completed
First Posted : September 28, 2004
Last Update Posted : April 10, 2017
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis | Drug: MK0663, etoricoxib Drug: Comparator: Diclofenac sodium | Phase 3 |
The duration of treatment is 12 months.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 6000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (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 |
| Actual Study Start Date : | June 27, 2002 |
| Actual Primary Completion Date : | November 1, 2003 |
| Actual Study Completion Date : | November 1, 2003 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
Primary Outcome Measures :
- Discontinuations due to clinical and laboratory gastrointestinal adverse experiences during a 1 year treatment period.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092703
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Study Data/Documents: CSR Synopsis
Publications:
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00092703 History of Changes |
| Other Study ID Numbers: |
0663-061 2004_052 |
| First Posted: | September 28, 2004 Key Record Dates |
| Last Update Posted: | April 10, 2017 |
| Last Verified: | April 2017 |
Keywords provided by Merck Sharp & Dohme Corp.:
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Arcoxia |
Additional relevant MeSH terms:
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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Diclofenac Etoricoxib 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 Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors |