Osteo Arthritis of the KneesPhase 4KAPSNCT02178137
Effect of Interventions on the Progression of Knee Osteoarthritis
A Phase 4 study testing Diacerien and Glucosamine/Chondroitin in people with Osteo Arthritis of the Knees, run by Indus Hospital and Health Network at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Osteo Arthritis of the Knees
- What is being tested?
- Diacerien and Glucosamine/Chondroitin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2014to Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Diacerien, Glucosamine/Chondroitin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiacerienDrug
Also called Artrodar, Dirtacetylrhein
Glucosamine/ChondroitinDrug
PlaceboDrug
Also called Zinc Sulphate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Diacerien |
| Placebo pill | Placebo comparator | Placebo tablets with Zinc sulfate twice a day. These will contain pharamacologically non active ingredients (Usually expedients). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 months
Mean differences in blood serum COMP levels of study arms
Measured: 24 months
Secondary outcomes (6)
Change in WOMAC score at 6 months in comparison to baseline score
Measured: 6 months
Change in WOMAC score at 12 months in comparison to baseline score
Measured: 12 months
Change in WOMAC score at 18 months in comparison to baseline score
Measured: 18 months
Change to the SF-36 score at 6 months in comparison to baseline score
Measured: 6 months
Change to the SF-36 score at 12 months in comparison to baseline score
Measured: 12 months
Change to the SF-36 score at 18 months in comparison to baseline score
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the KneesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indus Hospital and Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansoor Ali Khan, Indus Hospital and Health Network
- Investigators
- Mansoor A Khan, MBBS, Principal investigator, The Indus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178137
- Sponsor's protocol ID
- TIH-Ortho-001
- Acronym
- KAPS
- Status last verified
- Feb 2018
- First submitted
- 27 Jun 2014
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02178137
- Acronym / sponsor ID
- KAPS / TIH-Ortho-001
- Conditions
- Osteo Arthritis of the Knees
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Indus Hospital and Health NetworkUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucosamine/Chondroitin | Active comparator | Drug: Glucosamine/ChondroitinGlucosamine/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 | Active comparator | Drug: DiacerienDiacerien 50 mg twice a day in capsule form. To be taken twice a day after breakfast and dinner |
| Placebo pill | Placebo comparator | Drug: PlaceboPlacebo tablets with Zinc sulfate twice a day. These will contain pharamacologically non active ingredients (Usually expedients). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiacerienAlso: Artrodar, Dirtacetylrhein | Drug | Diacerien |
| Glucosamine/Chondroitin | Drug | Glucosamine/Chondroitin |
| PlaceboAlso: Zinc Sulphate | Drug | Placebo pill |
Primary outcome
Change in WOMAC score at 24 months in comparison to baseline score
Time frame: baseline, 24 months
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
Time frame: 24 months
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
Time frame: 24 months
6 secondary outcomes
Change in WOMAC score at 6 months in comparison to baseline score
Time frame: 6 months
Change in WOMAC score at 12 months in comparison to baseline score
Time frame: 12 months
Change in WOMAC score at 18 months in comparison to baseline score
Time frame: 18 months
Change to the SF-36 score at 6 months in comparison to baseline score
Time frame: 6 months
Change to the SF-36 score at 12 months in comparison to baseline score
Time frame: 12 months
Change to the SF-36 score at 18 months in comparison to baseline score
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansoor A Khan, MBBS principal investigator
The Indus Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diacerien and Glucosamine/Chondroitin in people with Osteo Arthritis of the Knees, run by Indus Hospital and Health Network at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WOMAC score at 24 months in comparison to baseline score (time frame: baseline, 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.