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

Phase 4 Study of Diacerein as Adjuvant to Diclofenac Sodium in Indian Patients of OA Knee

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Osteoarthritis, Knee
• Intervention / Treatment: Drug: diacerein

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
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Punjab
    • Amritsar, Punjab, India, 143001
      • Kuljinder Singh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Visual Analogue scale assessment of pain .

Secondary Outcome Measures

Outcome Measure
WOMAC assessment of pain, physical function
Global patient and physician assessment of pain and function
Paracetamol consumption

Collaborators and Investigators

• Sponsor: Government Medical College, Amritsar
• Investigators: Principal Investigator: Kuljinder Singh, MD, GMC Amritsar; Study Chair: Jaswant rai, MD, GMC Amritsar; Study Chair: Rakesh sharma, MS, GMC Amritsar

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 7, 2010
• First Posted (Estimate): May 10, 2010

Study Record Updates

• Last Update Posted (Estimate): May 31, 2010
• Last Update Submitted That Met QC Criteria: May 28, 2010
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: knee; OA
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Anti-Inflammatory Agents; Diacetylrhein
• Other Study ID Numbers: KS1