Clinical trial NCT01906801: Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Glucosamine
Diacerein
Keywords: Osteoarthritis
Glucosamine sulfate
Diacerein
Randomized controlled trial
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 148
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: pain visual analog scores
timeFrame: 24 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores
timeFrame: 24 weeks
measure: actual and change of joint space width
timeFrame: 24 weeks
measure: Rate of gastrointestinal side effects
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University, Thailand.
name: Patarawan Woratanarat, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand
name: Ammarin Thakkinstian, Ph.D
role: STUDY_CHAIR
References:
citation: Kongtharvonskul J, Woratanarat P, McEvoy M, Attia J, Wongsak S, Kawinwonggowit V, Thakkinstian A. Efficacy of glucosamine plus diacerein versus monotherapy of glucosamine: a double-blind, parallel randomized clinical trial. Arthritis Res Ther. 2016 Oct 12;18(1):233. doi: 10.1186/s13075-016-1124-9.