![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
CrystalGenomics, Inc. Quintiles |
---|---|
Information provided by: | CrystalGenomics, Inc. |
ClinicalTrials.gov Identifier: | NCT00530452 |
The primary objective of this study is to evaluate the safety and efficacy of 3 loading and maintenance dose levels of CG100649 administered for 21 days in the treatment of osteoarthritis pain.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis, Knee Osteoarthritis, Hip |
Drug: CG100649 Drug: Silicified microcrystalline cellulose + talc |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | Double-Blind, Placebo Controlled Phase II Repeat Dose Study of the Safety and Efficacy of Three Parallel Loading and Maintenance Dose Regimens of CG100649 Versus Placebo for the Treatment of Primary Osteoarthritis in Male Subjects |
Estimated Enrollment: | 240 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
2.0 mg (loading dose, Day 0) followed by 0.3 mg/day (Days 1-20)
|
Drug: CG100649
Dual-acting COX-2 inhibitor & carbonic anhydrase inhibitor in gelatin capsules. Oral loading doses (2, 4, or 8 mg vs. placebo) followed by daily oral maintenance doses (0.3, 0.6, or 1.2 mg vs. placebo) for 20 days (total 21 days therapy).
|
B: Experimental
4.0 mg (loading dose, Day 0) followed by 0.6 mg/day (Days 1-20)
|
Drug: CG100649
Dual-acting COX-2 inhibitor & carbonic anhydrase inhibitor in gelatin capsules. Oral loading doses (2, 4, or 8 mg vs. placebo) followed by daily oral maintenance doses (0.3, 0.6, or 1.2 mg vs. placebo) for 20 days (total 21 days therapy).
|
C: Experimental
8.0 mg (loading dose, Day 0) followed by 1.2 mg/day (Days 1-20)
|
Drug: CG100649
Dual-acting COX-2 inhibitor & carbonic anhydrase inhibitor in gelatin capsules. Oral loading doses (2, 4, or 8 mg vs. placebo) followed by daily oral maintenance doses (0.3, 0.6, or 1.2 mg vs. placebo) for 20 days (total 21 days therapy).
|
D: Placebo Comparator
Placebo (identical number of capsules to active drug groups) (Days 0-20)
|
Drug: Silicified microcrystalline cellulose + talc
Gelatin capsules containing cellulose/talc matched for weight and color to experimental medication. Placebo administered orally 1x/day.
|
This is a double-blind, placebo-controlled study. Subjects will discontinue current medications 5-14 days prior to randomization. Paracetamol (acetaminophen; ≤2 gm/day) may be used for breakthrough pain. Other NSAIDs, COX-2 inhibitors, opioids, and corticosteroids may not be used at any time during this study. Only subjects recording average DPI of 4 to 8 on a 0-10 numerical rating scale for at least 3 days, and no greater than 9 for more than 1 day, during the last 5 days of the washout period and meeting all other inclusion criteria will be randomized into the study.
Subjects meeting screening criteria will be randomized to receive 21 days dosing of an active dose of CG100649 or placebo.
Antiarthritic efficacy will be evaluated by changes in the Western Ontario and McMaster Universities (WOMAC) OA index completed on Day 0 (Baseline) and on Days 7, 14, 21, 28, and 35. DPI and functional interference (BPI scales) will be evaluated by subject diary during the screening period and on all study days through Day 35. Pain Relief will be evaluated on Days 7, 14, 21, 28, and 35.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stefania Di Credico | +39 02 95794.1 | stefania.decredico@quintiles.com |
Contact: Bernard Chung | 510-594-8200 | bernard@cgpharma.com |
Germany, Baden-Württemberg | |
Orthopaedische Praxis | Recruiting |
Bad Dürrheim, Baden-Württemberg, Germany, BW 78073 | |
Principal Investigator: Klaus Lehnhardt, Dr. med. |
Study Director: | William K Schmidt, PhD | CrystalGenomics, Inc. |
Responsible Party: | CrystalGenomics, Inc. ( William K. Schmidt, PhD ) |
Study ID Numbers: | CG100649-2-01, EudraCT number: 2007-001197-93 |
Study First Received: | September 13, 2007 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00530452 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Ukraine: State Pharmacological Center - Ministry of Health |
COX-2 carbonic anhydrase osteoarthritis anti-inflammatory Cyclooxygenase Inhibitors |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Osteoarthritis, Hip |