Osteoarthritis, KneePhase 4DRIPNCT02821468
Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN
A Phase 4 study testing Droglican and Paracetamol or oral NSAIDs excluding COX2 inhibitors in people with Osteoarthritis, Knee, run by Bioiberica at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Droglican and Paracetamol or oral NSAIDs excluding COX2 inhibitors
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Femorotibial knee OA (Uni- or bilateral)
- Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
- Symptomatic for more than 6 months in the most painful knee
- Radiological K\&L grade II-III in radiographs from less than 12 months
- Moderate-to-severe knee pain: knee pain score evaluated on Visual Analogue Scale (VAS) (0-100) ≥ 40 over the last 24 hours at the inclusion visit (the most painful knee is considered)
- Able to follow the instructions of the study
- Having signed an informed consent
Who cannot join
- Related to the OA pathology
- Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
- Concurrent articular disease interfering with the evaluation of OA and/or pain such as articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis, etc.
- Radiological K\&L grade I or IV
- Prosthesis in the target knee
- Related to treatments
Show all 30Show fewer
- Analgesics to manage OA knee pain 24h before inclusion visit
- Corticosteroids injection in the target knee in the month preceding inclusion
- Hyaluronan injection in the target knee in the last 6 months
- Oral corticotherapy ≥ 5mg/day in the last 3 months
- Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
- An anticipated need for any OA related medication for the duration of the trial (Corticosteroids or hyaluronan injection, Oral corticotherapy, Arthroscopy, analgesics other than the authorized rescue treatments) which are forbidden during the trial
- Arthroscopy in the last 6 months
- Patients with known allergy to CS, GH, or intolerance to rescue treatment (Paracetamol and NSAIDs)
- Patients with allergy to shellfish
- Related to associated diseases
- Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, tumor, HIV….)
- Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee Related to patients
- Artialis (study coordinator) or Bioiberica (Sponsor) 's employees
- Participation to a therapeutic clinical trial in the last 3 months
- Under guardianship or judicial protection
- Pregnancy, breastfeeding, planned conception
- Women without menopause or tubal ligation and without contraception
- Related to MRI
- Unable to receive gadopentetate contrast agent injection because of contraindications:
- Acute or chronic severe renal insufficiency (a glomerular filtration rate < 30 mL/min/1.73m2); or
- Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period.
- Known anaphylactic reactions to Gadolinium or related substances
- Risk groups for MRI scanning due to magnetic field or contrast agent: Metal in body: Pacemaker / Automatic Implantable Cardioverter Defibrillators / Implantable Cardioverter Defibrillators (coronary defibrillator), Nervus vagus stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insulin pump, Metal implants; f/e screws, prostheses, piercings.
- Claustrophobia, or serious mobility problem (Parkinson, tremors)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels
Anieska GIERASIMOWICZ - FONTANA, mherrero@bioiberica.com
About this study
Official title: Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN: a Pilot Study
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Droglican, Paracetamol or oral NSAIDs excluding COX2 inhibitors
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DroglicanDrug
Combined Chondroitin Sulfate 1200 mg + Glucosamine Hydrochloride 1500 mg
Paracetamol or oral NSAIDs excluding COX2 inhibitorsDrug
| Study group | Role | What they receive |
|---|---|---|
| Droglican | Experimental | Chondroitin Sulfate 1,200mg + Glucosamine Hydrochoride 1,500mg Receives: Drug: Droglican; Drug: Paracetamol or oral NSAIDs excluding COX2 inhibitors |
| Control | Experimental | Untreated arm Receives: Drug: Paracetamol or oral NSAIDs excluding COX2 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate change of composition of cartilage trough imaging marker (dGEMRIC)
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.
Measured: 6 months
Secondary outcomes (1)
Consumption of Rescue Medication
Use of rescue treatments (Paracetamol or oral NSAIDs excluding COX2 inhibitors)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artialis
- Responsible party
- Sponsor
- Investigators
- Josep Vergés, Study director, Bioiberica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821468
- Sponsor's protocol ID
- CL/BIO/2015-005 V5
- Acronym
- DRIP
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN: a Pilot Study
- ClinicalTrials.gov ID
- NCT02821468
- Acronym / sponsor ID
- DRIP / CL/BIO/2015-005 V5
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Collaborators
- Artialis
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 1 Jul 2016 (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.
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.
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Droglican | Experimental | Drug: Droglican, Drug: Paracetamol or oral NSAIDs excluding COX2 inhibitorsChondroitin Sulfate 1,200mg + Glucosamine Hydrochoride 1,500mg |
| Control | Experimental | Drug: Paracetamol or oral NSAIDs excluding COX2 inhibitorsUntreated arm |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Femorotibial knee OA (Uni- or bilateral)
- Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
- Symptomatic for more than 6 months in the most painful knee
- Radiological K\&L grade II-III in radiographs from less than 12 months
- Moderate-to-severe knee pain: knee pain score evaluated on Visual Analogue Scale (VAS) (0-100) ≥ 40 over the last 24 hours at the inclusion visit (the most painful knee is considered)
Key exclusion criteria (30 listed)
- Related to the OA pathology
- Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
- Concurrent articular disease interfering with the evaluation of OA and/or pain such as articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis, etc.
- Radiological K\&L grade I or IV
- Prosthesis in the target knee
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 |
|---|---|---|
| DroglicanCombined Chondroitin Sulfate 1200 mg + Glucosamine Hydrochloride 1500 mg | Drug | Droglican |
| Paracetamol or oral NSAIDs excluding COX2 inhibitors | Drug | Control, Droglican |
Primary outcome
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.
1 secondary outcome
Consumption of Rescue Medication
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Individual participant dataSharing planned: Yes
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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.
Josep Vergés study director
Bioiberica
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 Droglican and Paracetamol or oral NSAIDs excluding COX2 inhibitors in people with Osteoarthritis, Knee, run by Bioiberica at 1 site in Belgium.
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 7 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 1 Jul 2016. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Herrero (+34934904908, mherrero@bioiberica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate change of composition of cartilage trough imaging marker (dGEMRIC) (time frame: 6 months). 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 Jul 2016.