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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120015
• Other study ID #: ks1
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2010
• Last updated: May 28, 2010
• Start date: January 2007
• Est. completion date: November 2008

Study information

• Verified date: May 2009
• Source: Government Medical College, Amritsar
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
India	Kuljinder Singh	Amritsar	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Amritsar

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue scale assessment of pain .			No
Secondary	WOMAC assessment of pain, physical function
Secondary	Global patient and physician assessment of pain and function
Secondary	Paracetamol consumption