Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN (DRIP)
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|ClinicalTrials.gov Identifier: NCT02821468|
Recruitment Status : Unknown
Verified June 2016 by Bioiberica.
Recruitment status was: Recruiting
First Posted : July 1, 2016
Last Update Posted : July 1, 2016
A previous multicenter trial led by Bioiberica S.A. has confirmed the efficacy and safety of DROGLICAN for the treatment of osteoarthritis (OA) in patients with severe pain. The MOVES study was a phase IV, double blind, randomized and non-inferiority trial to compare the efficacy and safety of a fixed dose combination of glucosamine hydrochloride (GH) + chondroitin sulfate (CS) (DROGLICAN) versus celecoxib in patient with symptomatic knee OA with moderate to severe pain. This study concluded that both drugs reduced the WOMAC Pain subscale by 50% without significant difference between groups. Further, there was no difference in all secondary outcomes assessing patient's pain, functional capacity, stiffness, inflammation, joint swelling, effusion, and overall quality of life.
This new exploratory trial is aimed to evaluate the beneficial effect of DROGLICAN on the good health of the cartilage of patients suffering of knee osteoarthritis as revealed by qualitative assessment of cartilage biochemical composition in vivo.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: Droglican Drug: Paracetamol or oral NSAIDs excluding COX2 inhibitors||Phase 4|
This study is a post-marketing, open, exploratory, multicenter trial with 2 parallel-groups of patients suffering from knee OA. Investigators will be private or public hospital rheumatologists, general practitioners, or articular disease specialists located in Belgium.
After evaluation by the investigator during a control visit or via on site-patient registry, potential participants will be asked to perform an inclusion visit (V1). During this visit, the investigator will assess the eligibility of the patients. Eligible patients will sign an informed consent. The investigator will make a general evaluation (demography, medical history, OA history, OA medication history, concomitant medications including "rescue treatments") and a pain evaluation. Synovial fluid will be collected in case of knee swelling.
Blood samples will be collected in a preselected clinical laboratory for future biomarkers analyses.
Patients will be asked to perform an MRI exam within 20 days following the inclusion visit and representing the MRI at baseline. A standard X-ray will be performed at the same imaging site if the last X-ray available is not responding to high quality standard.
For DROGLICAN arm, patients will be given investigational medicinal product (IMP) for a 6-month period via the hospital pharmacy where image acquisition will be performed. IMP intake will begin right after baseline MRI acquisition. Study arm attribution will be determined according to the order of enrolment at each investigating site and using a randomization list.
All study subjects (receiving DROGLICAN or untreated control) will be allowed to take paracetamol and oral NSAIDs excluding COX2 inhibitors to relief knee pain. Patients will be asked to use these "rescue medications" only when needed during the trial, beginning by Paracetamol (up to 3g/day) and NSAIDs as a second-line medication, and will be told to reduce their use if they do not feel the need for them. The use of rescue treatments during the month prior to each visit will be recorded by the investigator in a Case Report Form (CRF). All other treatments for osteoarthritis will be forbidden during the course of the study.
Patients will return for consultation after 6 month (V2) and 12 months (V3). At each visit, the investigator will make a general evaluation, and will record concomitant medications including rescue medications, adverse events and drop-outs.
For DROGLICAN arm, compliance to the IMP will be assessed by counting unused capsules within the investigation kit brought back by the patient. At V2, patients will be given IMP for the next 6 months. Patients will be asked to return to the investigator all unused capsules of IMP at the next visit.
Blood samples and synovial fluid (if applicable) will be collected for future biomarkers analyses. MRI will be done at 6 months (V2) and optionally at 12 months (V3). Finally, an optional X-ray might be performed at V3 depending on the result of the interim analysis.
Monthly phone calls will be made by the investigator to assess and encourage patient's compliance (for DROGLICAN arm), to record potential adverse event, new concomitant treatment and/or drop-off.
Patients' clinical data will be recorded at each visit in a CRF.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN: a Pilot Study|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Chondroitin Sulfate 1,200mg + Glucosamine Hydrochoride 1,500mg
Combined Chondroitin Sulfate 1200 mg + Glucosamine Hydrochloride 1500 mg
Drug: Paracetamol or oral NSAIDs excluding COX2 inhibitors
Drug: Paracetamol or oral NSAIDs excluding COX2 inhibitors
- Evaluate change of composition of cartilage trough imaging marker (dGEMRIC) [ Time Frame: 6 months ]To evaluate the techniques for studying proteoglycans content: the delayed gadolinium enhanced magnetic resonance imaging of cartilage (dGEMRIC), after 6 months of treatment with DROGLICAN versus untreated control.
- Consumption of Rescue Medication [ Time Frame: 6 months ]Use of rescue treatments (Paracetamol or oral NSAIDs excluding COX2 inhibitors)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821468
|Contact: Marta Herrerofirstname.lastname@example.org|
|Contact: Anieska GIERASIMOWICZ - FONTANA email@example.com|
|Study Director:||Josep Vergés||Bioiberica|