Etoricoxib in the Treatment of Osteoarthritis
Information source: Merck
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks) (Drug); Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the
treatment of osteoarthritis of the knee.
Clinical Details
Official title: A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)
Secondary outcome: Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6
months prior to study entry (ARA class I, II, or III).
Positive therapeutic effect from prior NSAID therapy.
Worsening of symptoms upon withdrawal of prior treatment.
With the exception of OA, in otherwise good health
Exclusion Criteria:
Weight no more than 280 pounds (male or female).
Recent, sustained use of gastroprotective agents.
History of arthroscopy of the affected knee within 6 months prior to study entry.
History of acute ligamentous or meniscal injury of the study joint within the previous 2
years.
Locations and Contacts
Additional Information
Related publications: Gottesdiener K, Schnitzer T, Fisher C, Bockow B, Markenson J, Ko A, DeTora L, Curtis S, Geissler L, Gertz BJ; Protocol 007 Study Group. Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis. Rheumatology (Oxford). 2002 Sep;41(9):1052-61. Erratum in: Rheumatology (Oxford). 2003 Jun;42(6):814.
Starting date: June 1998
Last updated: December 15, 2006
|
