Diacerein as Adjuvant to Diclofenac Sodium in Indian Patients of Osteoarthritis (OA) Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01120015
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : May 31, 2010
Information provided by:
Government Medical College, Amritsar

Brief Summary:
The purpose of this study is to evaluate clinical effectiveness of diacerein as add on therapy to diclofenac sodium in Indian patients of osteoarthritis (OA) knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis Osteoarthritis, Knee Drug: diacerein Phase 4

Detailed Description:

Currently symptomatic relief is provided by the use of nonsteroidal anti-inflammatory drugs (NSAIDs) but they do not reverse the basic pathology of disease, rather may accelerate it, like degeneration of cartilage, inhibition of chondroitin synthesis and suppression of proteoglycans synthesis by the chondrocyte.

Research shows that IL-1β plays a fundamental role in osteoarthritis pathophysiology and cartilage destruction. Diacerein, a purified compound with anthraquinonic structure, inhibits IL-1β, retarding all pathological processes initiated in OA. Also, Diacerein has proven analgesic efficacy comparable to that of diclofenac in patients of osteoarthritis knee12. Because of these factors, the present study has been planned to evaluate the clinical effectiveness of diacerein as add on therapy to diclofenac sodium in Indian patients of symptomatic OA knee.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Diacerein as Adjuvant to Diclofenac Sodium in Indian Patients of OA Knee
Study Start Date : January 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Diacerein
diacerein 50mg oD first month, 50 mg BD next 2 months
Drug: diacerein
Diclofenac sodium 75mg sustained release tablet once daily was given to both groups for 3 months. Capsule diacerein 50mg in study group and matched placebo in control group were given once daily for first month and twice daily for next two months with the main meals.

Primary Outcome Measures :
  1. Visual Analogue scale assessment of pain .

Secondary Outcome Measures :
  1. WOMAC assessment of pain, physical function
  2. Global patient and physician assessment of pain and function
  3. Paracetamol consumption

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary osteoarthritis Patients recruited were between 35 to 60 years of age, with X-ray confirmed Kellgren-Lawrence grade13 II or III severity primary tibiofemoral OA, according to the American College of Rheumatology criteria.
  • Women of childbearing age had to provide evidence of adequate contraception prior to inclusion.

Exclusion Criteria:

Those patients were excluded from the present study who:

  • were of age less than 35 years or more than 60 years
  • presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
  • were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee
  • had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study
  • were having a known hypersensitivity to diclofenac sodium, to diacerein, to similar compounds, to the excipients or paracetamol, have history of painful knee conditions other than OA
  • have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin< 10.0 g/ dl or haematocrit < 30%).
  • Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01120015

Kuljinder Singh
Amritsar, Punjab, India, 143001
Sponsors and Collaborators
Government Medical College, Amritsar
Principal Investigator: Kuljinder Singh, MD GMC Amritsar
Study Chair: Jaswant rai, MD GMC Amritsar
Study Chair: Rakesh sharma, MS GMC Amritsar

Responsible Party: Kuljinder singh, Pharmacology department Identifier: NCT01120015     History of Changes
Other Study ID Numbers: ks1
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: May 31, 2010
Last Verified: May 2009

Keywords provided by Government Medical College, Amritsar:

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action