Osteoarthritis of the KneePhase 4NCT00805519
Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee
A Phase 4 study testing Glucosamine and chondroitin sulfate, glucosamine and chondroitin sulfate plus Prednisolone and Glucosamine and Chondroitin sulfate plus Chloroquine in people with Osteoarthritis of the Knee, run by Ardabil University of Medical Sciences at 1 site in Iran.
Trial summary
This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee which will be done in contrast to combined glucosamine sulfate and chondroitin. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Glucosamine and chondroitin sulfate, glucosamine and chondroitin sulfate plus Prednisolone and Glucosamine and Chondroitin sulfate plus Chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteIran
- Study dates
- Feb 2009to Apr 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and non-pregnant women, age 40-85 years with primary OA of at least one knee.
Who cannot join
- secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)corticosteroid use:
- oral corticosteroid within the previous 14 days
- intramuscular corticosteroid within 30 days
- intraarticular corticosteroid into the study knee within 90 days
- intra-articular corticosteroid into any other joint within 30 days or
- topical corticosteroid at the site of application within 14 days
Show all 12Show fewer
- ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management
- glucosamine or chondroitin within the previous six months
- history of alcohol or drug abuse
- lactation
- concomitant skin disease at the application site
- current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee Treated With Fixed Dose Combination of Glucosamine and Chondroitin Sulfate.
This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee which will be done in contrast to combined glucosamine sulfate and chondroitin.
Read the detailed description
Fixed dose glucosamine, chondroitin sulfate combination is a treatment to osteoarthritis with some controversy about efficacy. it seems that addition of other agents may improve efficacy and decrease the required dose and cost. common oral corticosteroids such as low dose prednisolone and chloroquine are candidate for such add on therapies. nevertheless, add on therapy may expose the patients to new side effects which should followed and addressed.
In this investigator blinded controlled trial, 240 patients with diagnosed osteoarthritis of knee will be enrolled to the study. the patients will randomly be assigned to one of four groups of G (glucosamine and chondroitin sulfate ), P (Glucosamine and Chondroitin sulfate plus Prednisolone), C (Glucosamine and Chondroitin sulfate plus Chloroquine) and PC (Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine). each group will consist 60 patients. the investigator(s) will be blind to the groups and interventions.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Glucosamine and chondroitin sulfate, glucosamine and chondroitin sulfate plus Prednisolone, Glucosamine and Chondroitin sulfate plus Chloroquine, Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine
- Keywords
- Osteoarthritis of the Knee, Glucosamine Chondroitin sulfate, Prednisolone, Chloroquine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine and chondroitin sulfateDrug
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.
glucosamine and chondroitin sulfate plus PrednisoloneDrug
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive Prednisolone 5 mg/day
Glucosamine and Chondroitin sulfate plus ChloroquineDrug
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive chloroquine 150 mg every two days.
Glucosamine,Chondroitin sulfate,Prednisolone,ChloroquineDrug
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive prednisolone 5 mg/day and chloroquine 150 mg every two days.
| Study group | Role | What they receive |
|---|---|---|
| Glucosamine and chondroitin sulfate | Active comparator | in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation Receives: Drug: Glucosamine and chondroitin sulfate |
| P :glucosa, chondroitin, Prednis | Experimental | in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration Receives: Drug: glucosamine and chondroitin sulfate plus Prednisolone |
| Glucosa, Chondroitin, Chloroquine | Experimental | in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine. Receives: Drug: Glucosamine and Chondroitin sulfate plus Chloroquine |
| Glucosa, Chondro, Prednis,Chloroq | Experimental | in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine Receives: Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA)
Measured: Baseline
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA)
Measured: the outcome is assessed at 6 weeks after baseline visit
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA)
Measured: the outcome is assessed at 12 weeks after baseline visit
Secondary outcomes (3)
The secondary measure will be changes in stiffness
Measured: the outcome is assessed at baseline visit
The secondary measure will be changes in stiffness
Measured: the outcome is assessed at 6 weeks after baseline visit
The secondary measure will be changes in stiffness
Measured: the outcome is assessed at 12 weeks after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardabil University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Shahab Bohlooli, PhD, Principal investigator, Pharmacology Dept, Faculty of Medicine, ArdabilUMSMarina Jastan, MD, Principal investigator, Rheomatology clinic, Faculty of Medicine, ArdabilUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805519
- Sponsor's protocol ID
- 870919
- Status last verified
- Apr 2010
- First submitted
- 8 Dec 2008
- Last updated
- 30 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee Treated With Fixed Dose Combination of Glucosamine and Chondroitin Sulfate.
- ClinicalTrials.gov ID
- NCT00805519
- Acronym / sponsor ID
- 870919
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis of the Knee, Glucosamine Chondroitin sulfate, Prednisolone, Chloroquine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Ardabil University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 Dec 2008 (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.
This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee which will be done in contrast to combined glucosamine sulfate and chondroitin.
Detailed description
Fixed dose glucosamine, chondroitin sulfate combination is a treatment to osteoarthritis with some controversy about efficacy. it seems that addition of other agents may improve efficacy and decrease the required dose and cost. common oral corticosteroids such as low dose prednisolone and chloroquine are candidate for such add on therapies. nevertheless, add on therapy may expose the patients to new side effects which should followed and addressed.
In this investigator blinded controlled trial, 240 patients with diagnosed osteoarthritis of knee will be enrolled to the study. the patients will randomly be assigned to one of four groups of G (glucosamine and chondroitin sulfate ), P (Glucosamine and Chondroitin sulfate plus Prednisolone), C (Glucosamine and Chondroitin sulfate plus Chloroquine) and PC (Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine). each group will consist 60 patients. the investigator(s) will be blind to the groups and interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glucosamine and chondroitin sulfate | Active comparator | Drug: Glucosamine and chondroitin sulfatein this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation |
| P :glucosa, chondroitin, Prednis | Experimental | Drug: glucosamine and chondroitin sulfate plus Prednisolonein this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration |
| Glucosa, Chondroitin, Chloroquine | Experimental | Drug: Glucosamine and Chondroitin sulfate plus Chloroquinein this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine. |
| Glucosa, Chondro, Prednis,Chloroq | Experimental | Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquinein this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men and non-pregnant women, age 40-85 years with primary OA of at least one knee.
Key exclusion criteria (12 listed)
- secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)corticosteroid use:
- ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management
- glucosamine or chondroitin within the previous six months
- history of alcohol or drug abuse
- lactation
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 |
|---|---|---|
| Glucosamine and chondroitin sulfateIn this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily. | Drug | Glucosamine and chondroitin sulfate |
| glucosamine and chondroitin sulfate plus PrednisoloneIn this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive Prednisolone 5 mg/day | Drug | P :glucosa, chondroitin, Prednis |
| Glucosamine and Chondroitin sulfate plus ChloroquineIn this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive chloroquine 150 mg every two days. | Drug | Glucosa, Chondroitin, Chloroquine |
| Glucosamine,Chondroitin sulfate,Prednisolone,ChloroquineIn this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive prednisolone 5 mg/day and chloroquine 150 mg every two days. | Drug | Glucosa, Chondro, Prednis,Chloroq |
Primary outcome
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA)
Time frame: Baseline
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA)
Time frame: the outcome is assessed at 6 weeks after baseline visit
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA)
Time frame: the outcome is assessed at 12 weeks after baseline visit
3 secondary outcomes
The secondary measure will be changes in stiffness
Time frame: the outcome is assessed at baseline visit
The secondary measure will be changes in stiffness
Time frame: the outcome is assessed at 6 weeks after baseline visit
The secondary measure will be changes in stiffness
Time frame: the outcome is assessed at 12 weeks after baseline visit
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 30 Apr 2010.
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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.
Shahab Bohlooli, PhD principal investigator
Pharmacology Dept, Faculty of Medicine, ArdabilUMS
Marina Jastan, MD principal investigator
Rheomatology clinic, Faculty of Medicine, ArdabilUMS
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 Glucosamine and chondroitin sulfate, glucosamine and chondroitin sulfate plus Prednisolone and Glucosamine and Chondroitin sulfate plus Chloroquine in people with Osteoarthritis of the Knee, run by Ardabil University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 12 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 30 Apr 2010. 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 Iran. 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. 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?
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA) (time frame: Baseline). 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 30 Apr 2010.