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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis; Diacerein; Glucosamine

Treatments: Drug: Diacerein; Drug: Placebo (for Diacerein); Drug: Glucosamine sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01906801

04-56-25

Details and patient eligibility

About

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

Enrollment: 148 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Adult patients age 50 years or older who have been diagnosed as primary or secondary osteoarthritis of the knee base on clinical criteria of American College of Rheumatology

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 2 patient groups

Glucosamine sulfate & Diacerein

Experimental group

Description:

Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks

Treatment:

Drug: Glucosamine sulfate

Drug: Diacerein

Glucosamine sulfate & Placebo

Active Comparator group

Description:

Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks

Treatment:

Drug: Glucosamine sulfate

Drug: Placebo (for Diacerein)