NCT00530452

Phase II Study of CG100649 for Primary Osteoarthritis in Male Subjects

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: CrystalGenomics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Osteoarthritis, Knee
• Osteoarthritis, Hip

Interventions

Type	Name	Description
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).
DRUG	Silicified microcrystalline cellulose + talc	Gelatin capsules containing cellulose/talc matched for weight and color to experimental medication. Placebo administered orally 1x/day.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-09-17
• Last updated: 2008-06-13

Locations

1 site across 1 country: Germany