Clinical Trial Results:
Evaluation of the evolution of imaging markers of cartilage degradation in patients with knee osteoarthritis receiving DROGLICAN®: a Pilot Study.
Summary
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EudraCT number |
2015-005681-37 |
Trial protocol |
BE |
Global end of trial date |
26 Nov 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Nov 2021
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First version publication date |
04 Nov 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CL/BIO/15-005
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Bioibérica, S.A.U
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Sponsor organisation address |
Pza Francesc Macià, 7, Barcelona , Spain, 08029
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Public contact |
Clinical Department , ARTIALIS S.A., investigators_clinicaltrials@artialis.com
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Scientific contact |
Clinical Department , ARTIALIS S.A., investigators_clinicaltrials@artialis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
26 Nov 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Nov 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Nov 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective was to evaluate the evolution of dGEMRIC (delayed Gadolinium-Enhanced Magnetic Resonance Imaging in Cartilage) imaging marker after 6 months of treatment with DROGLICAN®
The second objectives included the use of rescue treatments (Paracetamol, tramadol or oral NSAIDs, excluding COX2 inhibitors) and evaluation of safety and tolerability of the treatment.
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Protection of trial subjects |
The clinical trial has been performed according to GCP ICH E6 and the ethical principles that have their origins in the Declaration of Helsinki, last updated in Fortaleza 2013.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
29 Jun 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 22
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Worldwide total number of subjects |
22
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EEA total number of subjects |
22
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
22
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
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Pre-assignment
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Screening details |
Each patient who signed the informed consent form was considered as screened patient. Patients who signed an informed consent form but were not randomized were considered as screening failures. | ||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
Arms
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Arm title
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Test product DROGLICAN® | ||||||||||||||
Arm description |
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Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Chondroitin Sulphate (CS) 200mg / Glucosamine Hydrochloride (GH) 250mg
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Investigational medicinal product code |
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Other name |
DROGLICAN® 200mg/250mg hard-capsules
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
CS = Chondroitin Sulphate; GH = Glucosamine Hydrochloride
Daily dosage of CS 1200 mg and GH 1500 mg during 12 months administrated by taking DROGLICAN® 2 capsules to be taken 3 times a day.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
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Subject analysis sets
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Subject analysis set title |
DROGLICAN®
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All randomized patients who met the inclusion criteria, received study medication, had a baseline efficacy measurement and at least one corresponding post-baseline efficacy measurement (for the main efficacy variable) and did not present major violations of the protocol. FAS population with dGEMRIC index measured at baseline (T0) and after 6 months treatment (T6).
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End points reporting groups
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Reporting group title |
Test product DROGLICAN®
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Reporting group description |
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Subject analysis set title |
DROGLICAN®
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All randomized patients who met the inclusion criteria, received study medication, had a baseline efficacy measurement and at least one corresponding post-baseline efficacy measurement (for the main efficacy variable) and did not present major violations of the protocol. FAS population with dGEMRIC index measured at baseline (T0) and after 6 months treatment (T6).
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End point title |
Change of dGEMRIC index after 6 months of DROGLICAN® [1] | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Measure of the change of dGEMRIC index (imaging marker) of the cartilage at baseline (T0) and at after 6 months of treatment with DROGLICAN® (T6) for femoral, tibial and patellar cartilage segments (lateral and medial) by Magnetic Resonance Imaging.
dGEMRIC index values remained constants along the 6 months-treatment period and no statistically significant changes were found for any of the compartments.
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End point type |
Primary
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End point timeframe |
From baseline (T0) to 6 months after treatment with DROGLICAN® (T6).
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Since it was a single-arm study, the statistical analysis performed was descriptive and comparative with respect to baseline. The evolution of dGMERIC index between baseline and 6 months was evaluated using parametric t-test (within treatment differences). |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From baseline until the End of the Trial (mean follow up of 375 days for patients exposed to study treatment 12 months).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Safety population
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Reporting group description |
All randomized patients who took at least one dose of the study medication. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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12 Dec 2016 |
Amendment to the protocol to allow the intake of the active treatment to all the patients included in the trial. The amendment responded to investigators remarks about patients' unwillingness to be allocated to the un-treated arm group. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |