Effect of Interventions on the Progression of Knee Osteoarthritis

NCT ID: NCT02178137

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-10-31

Brief Summary

There has been intensive search for a substance that can have disease-modifying activity for osteoarthritis. A number of medications have been reported to be of benefit on slowing progression of knee OA. This trial will be the first head to head comparison of these medications.

Patients aged between age 40 to 65 will be enrolled. Patients will be assessed clinically using two scoring systems, the WOMAC index for knee arthritis and the SF 36 for overall physical and mental health. The knee X rays will be assessed on Kellgren and Lawrence grading and will also be measured for joint space narrowing at follow up. The response to arthritis medications on slowing down cartilage loss will be measured biochemically with COMP levels.

Conditions

Osteo Arthritis of the Knees

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Glucosamine/Chondroitin

Glucosamine/Chondroitin twice a day for a daily total dose of 1500 mg of Glucosamine and 1200 mg of Chondroitin.

Tablets will have 750 mg Glucosamine Sulphate and 600 mg of Chondroitin Sulphate. These will be taken twice a day after breakfast and dinner.

Group Type: ACTIVE_COMPARATOR

Glucosamine/Chondroitin

Intervention Type: DRUG

Diacerien

Diacerien 50 mg twice a day in capsule form. To be taken twice a day after breakfast and dinner

Group Type: ACTIVE_COMPARATOR

Diacerien

Intervention Type: DRUG

Placebo pill

Placebo tablets with Zinc sulfate twice a day. These will contain pharamacologically non active ingredients (Usually expedients).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Diacerien

Intervention Type: DRUG

Glucosamine/Chondroitin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Artrodar; Dirtacetylrhein; Zinc Sulphate

Eligibility Criteria

Inclusion Criteria

• Patients of either sex aged between 40 to 65 years with mild to moderate osteoarthritis of the knees.
• Patients should have history of knee pain for at least 6 months and on the majority of days during the preceding month
• Each joint will be scored separately so one patient with bilateral knee osteoarthritis will be counted as 2 knees.
• The osteoarthritis will be graded on basis of clinical score as well as seen on appropriately positioned x rays using the Kellgren and Lawrence grading. (Tibio femoral osteophytes of at least 1 mm, Kellgren Lawrence grading of 2 or 3)
• Patients with diabetes are sent to the diabetes clinic and are included once their HbA1c level becomes normal.
• Patients giving Informed consent

Exclusion Criteria

• Patients with severe end stage tricompartmental osteoarthritis of the knees .
• Presence of uncontrolled systemic disease like chronic liver and renal disease
• Patients with diagnosis other than osteoarthritis, such as knee arthritis due to rheumatoid disease, gout, post traumatic arthritis
• Patients with history of surgery to any knee will have that knee excluded
• Pregnant or lactating mothers
• Patients with chronic anaemia
• Patients who get an injection in their affected knee

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indus Hospital and Health Network

OTHER

Sponsor Role: lead

Responsible Party

Mansoor Ali Khan

Professor, Orthoepedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mansoor A Khan, MBBS

Role: PRINCIPAL_INVESTIGATOR

The Indus Hospital

Locations

The Indus Hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

TIH-Ortho-001

Identifier Type: -

Identifier Source: org_study_id