Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine

Phase 4

Completed

• Conditions: Diacerein; Osteoarthritis; Glucosamine
• Interventions: Drug: Glucosamine sulfate; Drug: Placebo (for Diacerein); Drug: Diacerein

• Registration Number: NCT01906801
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24 weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine in OA patients

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-20
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-24
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Clinical diagnosis of primary osteoarthritis
• Mild deformity Clinical (having no varus or valgus deformity, no crepitus) ? Physical examination grade 0 assessed by stress test Radiographic assessment (Kellgrane-lawrance type II-III), a minimum baseline medial tibiofemoral JSW of _2 mm.
• Willing to participate and provide written informed consent

Exclusion Criteria

• Non-secondary osteoarthritis Rheumatoid arthritis, inflammatory arthritis (e.g. SLE, Gout), post traumatic osteoarthritis, those who received intra-articular treatment of the signal joint with any product (corticosteroids in the previous 2 months, or glycosaminoglycans/hyaluronic acid in the previous 6 months) or had undergone joint lavage andarthroscopic procedures in the previous 6 months.
• No contraindication of using diacerein and glucosamine
• Non-current or ex-users of oral SYSADOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics known hypersensitivity to diacerein, to similar compounds, to the excipients or to paracetamol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucosamine sulfate & Diacerein	Glucosamine sulfate	Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks
Glucosamine sulfate & Placebo	Glucosamine sulfate	Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks
Glucosamine sulfate & Placebo	Placebo (for Diacerein)	Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks
Glucosamine sulfate & Diacerein	Diacerein	Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
pain visual analog scores	24 weeks

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores	24 weeks
actual and change of joint space width	24 weeks
Rate of gastrointestinal side effects	24 weeks

Trial Locations

Locations (1)

Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University; 🇹🇭 Bangkok, Thailand