Clinical Trial: Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis

Brief Summary: This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to assess the safety of GB-0998.

Detailed Summary:
Sponsor: Benesis Corporation

Current Primary Outcome: Changes in TSS at 12 weeks

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in joint motion, oral aperture, active hand spread, fingertip-to-palm distance, health assessment questionnaire, histological analysis of dermal section at 12 weeks.; Adverse events and laboratory test.

Original Secondary Outcome: Same as current

Information By: Benesis Corporation

Dates:
Date Received: July 3, 2006
Date Started: July 2006
Date Completion:
Last Updated: July 28, 2010
Last Verified: July 2010