MedTrace Logo

Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis

NCT03755258 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2018-11-27

No results posted yet for this study

Summary

This is a phase Ib study to investigate the safety, pharmacokinetics and preliminary efficacy of ginsenoside compound K (GCK) tablets in patients with rheumatoid arthritis. This study is to be run in China involving 10-12 sites. It will enroll approximately 240 patients to ensure 128 randomized with active rheumatoid arthritis. The treatment period is 12 weeks and total study duration per patient is approximately 14 weeks.

Conditions

  • Early Rheumatoid Arthritis

Interventions

DRUG

GCK 100 mg + Placebo 200 mg

GCK 100 mg + Placebo 200 mg, oral, 12 weeks

DRUG

GCK 200 mg + Placebo 100 mg

GCK 200 mg + Placebo 100 mg, oral, 12 weeks

DRUG

GCK 300 mg

GCK 300 mg, oral, 12 weeks

DRUG

Placebo 300mg

Placebo 300mg, oral, 12 weeks

Sponsors & Collaborators

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Yin Su, PhD · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2019-07-11
Completion
2019-12-11

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03755258 on ClinicalTrials.gov