Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2016-06-24
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Bonolive
Bonolive
2 caps per day of Bonolive
Placebo
Placebo
2 caps per day of Placebo
Interventions
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Bonolive
2 caps per day of Bonolive
Placebo
2 caps per day of Placebo
Eligibility Criteria
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Inclusion Criteria
* BMI between 18.5 and 29.9 kg/m2 (normo and overweight)
* Moderate knee pain (the most painful knee is considered)
* Able to follow the instructions of the study
* Able to perform physical tests
* Having signed an informed consent
Exclusion Criteria
* Recent trauma (\< 1 month) of the knee responsible of the symptomatic knee
* Subject with knee/joint surgery/replacement and ACL (Cross Ligament) injury in the target knee
* Concurrent articular disease interfering with the evaluation of 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
* Prosthesis in the target knee
* Diagnosed arthrosis eligible to knee/joint surgery/replacement
Related to treatments
* Analgesics to manage 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
* Other dietary supplements used for articular disorders in the last 3 months
* An anticipated need for the duration of the trial of corticosteroids or hyaluronan injection, oral corticotherapy, arthroscopy, analgesics other than listed as rescue treatments, which are forbidden during the trial
* Arthroscopy in the last 6 months
* Allergy or contra-indication to Oleuropein, to maltodextrin or any ingredient present in the product, or intolerance to rescue treatment (Paracetamol and NSAIDs)
* Treatments based on strontium ranelate, bisphosphonates, selective estrogen-receptor modulator (SERM) and parathormone (PTH) during the year before inclusion
Related to associated diseases
* Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, Parkinson, progressive malignant neoplasia or in remission for less than 5 years, HIV, etc.)
* Lower or upper extremity surgery or fracture in the last 3 months
* Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
* Swallowing disorder
Related to patients
* Close collaborators to the investigational team, the study coordinator (Artialis) or to the Sponsor (Nestlé)
* Currently participating or having participated in another therapeutic clinical trial in the three previous months
* Having made a blood donation in the past month
* Under guardianship or judicial protection
* Pregnancy, breastfeeding, planned conception
* Premenopausal women or women without tubal ligation or contraception.
55 Years
ALL
Yes
Sponsors
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Artialis
INDUSTRY
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Countries
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Other Identifiers
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15.16.CLI
Identifier Type: -
Identifier Source: org_study_id
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