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OpenTrials
Completed

NCT Number: NCT01906801

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

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucosamine Sulfate

Drug

Other names: Viatril-S

Diacerein

Drug

Other names: Artrodar

Placebo (for Diacerein)

Drug

Sugar pill manufactured to mimic Diacerein 50 mg tablet

Primary outcomes

  1. pain visual analog scores

    Time frame: 24 weeks

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores

    Time frame: 24 weeks

  2. actual and change of joint space width

    Time frame: 24 weeks

  3. Rate of gastrointestinal side effects

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2013
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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