Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN

NCT02821468 | Unknown Phase 4

• 1 other identifier: CL/BIO/2015-005 V5
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Consumption of Rescue Medication

  6 months

Study Arms (2)

Droglican

EXPERIMENTAL

Chondroitin Sulfate 1,200mg + Glucosamine Hydrochoride 1,500mg

Drug: Droglican; Drug: Paracetamol or oral NSAIDs excluding COX2 inhibitors

Control

EXPERIMENTAL

Untreated arm

Drug: Paracetamol or oral NSAIDs excluding COX2 inhibitors

Interventions

Droglican DRUG

Combined Chondroitin Sulfate 1200 mg + Glucosamine Hydrochloride 1500 mg

Droglican

Paracetamol or oral NSAIDs excluding COX2 inhibitors DRUG

Control; Droglican

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to follow the instructions of the study
• Having signed an informed consent

You may not qualify if:

• 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
• 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….)

Sponsors & Collaborators

• Bioiberica: lead
• Artialis: collaborator

Study Sites (1)

CHU Brugmann

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Josep Vergés

  Bioiberica

  STUDY DIRECTOR

Central Study Contacts

Marta Herrero

CONTACT

+34934904908; mherrero@bioiberica.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: July 1, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: July 1, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)