Effect of Interventions on the Progression of Knee Osteoarthritis

NCT02178137 | Completed Phase 4 DMC

• 1 other identifier: TIH-Ortho-001
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in WOMAC score at 24 months in comparison to baseline score

  Hypothesis:- At least one of the intervention drug will result in an improvement of at least 20 points on the WOMAC score at end of 2 years as compared to the placebo when compared to base line score

  baseline, 24 months

• Change to the SF-36 score at 24 months in comparison to baseline score

  Hypothesis: At least one of the intervention drugs will result in an improvement of at least 20 points at end of two years when assessed using the SF36 total score as compared to the standard therapy placebo when compared with baseline score

  24 months

• Mean differences in blood serum COMP levels of study arms

  24 months

Secondary Outcomes (6)

• Change in WOMAC score at 6 months in comparison to baseline score

  6 months

• Change in WOMAC score at 12 months in comparison to baseline score

  12 months

• Change in WOMAC score at 18 months in comparison to baseline score

  18 months

• Change to the SF-36 score at 6 months in comparison to baseline score

  6 months

• Change to the SF-36 score at 12 months in comparison to baseline score

  12 months

Study Arms (3)

Glucosamine/Chondroitin

ACTIVE COMPARATOR

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.

Drug: Glucosamine/Chondroitin

Diacerien

ACTIVE COMPARATOR

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

Drug: Diacerien

Placebo pill

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Diacerien DRUG

Also known as: Artrodar, Dirtacetylrhein

Diacerien

Glucosamine/Chondroitin DRUG

Glucosamine/Chondroitin

Placebo DRUG

Also known as: Zinc Sulphate

Placebo pill

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indus Hospital and Health Network: lead

Study Sites (1)

The Indus Hospital

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

diacerein; Glucosamine; Chondroitin; Zinc Sulfate

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Glycosaminoglycans; Polysaccharides; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Mansoor A Khan, MBBS

  The Indus Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Orthoepedics

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: June 30, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

PA (1)