Status:
COMPLETED
Hydrolyzed Fish Cartilage Effect on Knee Joint Functionality and Discomfort in Adult Population
Lead Sponsor:
Abyss Ingredients
Collaborating Sponsors:
Artialis
Conditions:
Knee Discomfort
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
This study is an exploratory, non-comparative, multi-centric trial in 30 free-living healthy male and female subjects with moderate knee joint discomfort and loss of functionality. The objective of t...
Detailed Description
30 patients will be enrolled during a 4-month period in 3 investigational sites and each patient will undergo 3 visits (V0: Inclusion visit at baseline, V1: Follow-Up Visit after 1 month ± 3 day and V...
Eligibility Criteria
Inclusion
- Male or female
- Age limits (see above)
- Body Mass Index BMI ≤ 35 kg/m2
- Knee discomfort score at rest over the last 24 hours on the most painful knee evaluated on VAS (0-100) ≥ 40 at baseline
- Able to follow the instructions of the study
- Having signed an informed consent
Exclusion
- related to knee:
- Recent trauma (\< 1 month) of the knee responsible of the symptomatic knee;
- Concurrent articular disease interfering with the evaluation of knee pain left to the Investigator's discretion
- Prosthesis in the target knee
- related to treatments:
- Analgesics to manage knee pain 24 hours before inclusion visit;
- Corticosteroids injection in the target knee in the last month;
- Hyaluronan injection in the target knee in the last 6 months;
- Arthroscopy in the last 6 months
- Oral corticotherapy ≥ 5mg/day (in Prednisolone equivalent) in the last 3 months;
- Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) or dietary supplement, i.e., curcuma extract, chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables int he last 3 months
- Contraindications to Cartidyss: hypersensitivity or allergy to the product components (fish)
- Treatments based on strontium ranelate, bisphosphonates, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months
- related to associated diseases :
- Any severe, uncontrolled and limiting diseases left to the Investigator's discretion
- Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
- Anticipated need for any forbidden treatments during the trial
- Swallowing disorder
- Patient with widespread pain/depression (e.g. fibromyalgia)
- related to patients:
- Close collaborators to the investigational team, the study coordinator or to the Sponsor
- Currently participating or having participated in another therapeutic clinical trial in the last 3 months
- Under guardianship or judicial protection
- Pregnancy, breastfeeding, planned conception, or premenopausal women without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device), tubal ligation or hysterectomy
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04420091
Start Date
June 11 2020
End Date
December 17 2020
Last Update
January 6 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre medical Chant d'Oiseau
Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, Belgium, 1150
2
Hopital Princesse Paola, VIVALIA
Marche-en-Famenne, Belgium, 6900