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

Phase 3

Completed

• Conditions: Scleroderma, Systemic

• Registration Number: NCT00348296
• Lead Sponsor: Benesis Corporation

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 Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-03
• Study First Submitted QC: 2006-07-03
• Study First Posted: 2006-07-04
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-28
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients who have sclerosis located proximal to the elbow joint with diffused systemic scleroderma.
• Patients who have not less than 20 points of TSS.
• Patients with no appropriate therapeutic treatment.

Exclusion Criteria

• Patients with severe hepatic disorder, severe renal disorder or severe heart disorder.
• Patients with malignant tumors.
• Patients who have the anamnesis of shock or hypersensitivity to this drug.
• Patients who have the anamnesis of cerebral infarction or symptom of these diseases.
• Patients who have been diagnosed as IgA deficiency in their past history.
• Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant.
• Patients who had any dose increase or new dosing of steroid within 12 weeks before consent.
• Patients who were administered other investigational drug within 12 weeks before consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in TSS at 12 weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nagasaki University; 🇯🇵 Nagasaki, Japan