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Effect of Interventions on the Progression of Knee Osteoarthritis (KAPS)

Primary Purpose

Osteo Arthritis of the Knees

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Diacerien
Glucosamine/Chondroitin
Placebo
Sponsored by
Indus Hospital and Health Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis of the Knees

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Indus Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Glucosamine/Chondroitin

Diacerien

Placebo pill

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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
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
Mean differences in blood serum COMP levels of study arms

Secondary Outcome Measures

Change in WOMAC score at 6 months in comparison to baseline score
Change in WOMAC score at 12 months in comparison to baseline score
Change in WOMAC score at 18 months in comparison to baseline score
Change to the SF-36 score at 6 months in comparison to baseline score
Change to the SF-36 score at 12 months in comparison to baseline score
Change to the SF-36 score at 18 months in comparison to baseline score

Full Information

First Posted
June 27, 2014
Last Updated
February 28, 2018
Sponsor
Indus Hospital and Health Network
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1. Study Identification

Unique Protocol Identification Number
NCT02178137
Brief Title
Effect of Interventions on the Progression of Knee Osteoarthritis
Acronym
KAPS
Official Title
Effect of Interventions on Progression of Knee Osteoarthritis - a Comparison of Effect of Glucosamine/Chondroitin or Diacerin Vs Placebo: Measured by Clinical, Radiological and Biochemical Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indus Hospital and Health Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis of the Knees

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucosamine/Chondroitin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diacerien
Arm Type
Active Comparator
Arm Description
Diacerien 50 mg twice a day in capsule form. To be taken twice a day after breakfast and dinner
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Arm Description
Placebo tablets with Zinc sulfate twice a day. These will contain pharamacologically non active ingredients (Usually expedients).
Intervention Type
Drug
Intervention Name(s)
Diacerien
Other Intervention Name(s)
Artrodar, Dirtacetylrhein
Intervention Type
Drug
Intervention Name(s)
Glucosamine/Chondroitin
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Zinc Sulphate
Primary Outcome Measure Information:
Title
Change in WOMAC score at 24 months in comparison to baseline score
Description
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
Time Frame
baseline, 24 months
Title
Change to the SF-36 score at 24 months in comparison to baseline score
Description
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
Time Frame
24 months
Title
Mean differences in blood serum COMP levels of study arms
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in WOMAC score at 6 months in comparison to baseline score
Time Frame
6 months
Title
Change in WOMAC score at 12 months in comparison to baseline score
Time Frame
12 months
Title
Change in WOMAC score at 18 months in comparison to baseline score
Time Frame
18 months
Title
Change to the SF-36 score at 6 months in comparison to baseline score
Time Frame
6 months
Title
Change to the SF-36 score at 12 months in comparison to baseline score
Time Frame
12 months
Title
Change to the SF-36 score at 18 months in comparison to baseline score
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansoor A Khan, MBBS
Organizational Affiliation
The Indus Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Indus Hospital
City
Karachi
State/Province
Sind
Country
Pakistan

12. IPD Sharing Statement

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Effect of Interventions on the Progression of Knee Osteoarthritis

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