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

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906801
• Other study ID #: 04-56-25
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2013
• Last updated: May 25, 2017
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2017
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diacerein
• Glucosamine
• Osteoarthritis

Intervention

Drug:
• Glucosamine sulfate

• Diacerein

• Placebo (for Diacerein)
Sugar pill manufactured to mimic Diacerein 50 mg tablet

Locations

Country	Name	City	State
Thailand	Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain visual analog scores		24 weeks
Secondary	Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores		24 weeks
Secondary	actual and change of joint space width		24 weeks
Secondary	Rate of gastrointestinal side effects		24 weeks