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

NCT01120015 | Completed Phase 4

• 1 other identifier: ks1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Osteoarthritis, Knee

Keywords

OA; knee

Outcome Measures

Primary Outcomes (1)

• Visual Analogue scale assessment of pain .

Secondary Outcomes (3)

• WOMAC assessment of pain, physical function

• Global patient and physician assessment of pain and function

• Paracetamol consumption

Study Arms (1)

Diacerein

EXPERIMENTAL

diacerein 50mg oD first month, 50 mg BD next 2 months

Drug: diacerein

Interventions

diacerein DRUG

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.

Diacerein

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Medical College, Amritsar: lead

Study Sites (1)

Kuljinder Singh

Amritsar, Punjab, 143001, India

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

diacerein

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kuljinder Singh, MD

  GMC Amritsar

  PRINCIPAL INVESTIGATOR

• Jaswant rai, MD

  GMC Amritsar

  STUDY CHAIR

• Rakesh sharma, MS

  GMC Amritsar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 10, 2010
• Study Start: January 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 31, 2010

Record last verified: 2009-05

Locations

IN (1)