A double-blind, active-controlled, randomized, parallel group multicentric study to investigate the safety, tolerability and efficacy of reparagen - a dietary supplement compared to glucosamine sulphate in patients with moderate osteoarthritis of the knee
- Conditions
- Moderate osteoarthritis of the kneeMusculoskeletal DiseasesOsteoarthritis
- Registration Number
- ISRCTN25438351
- Lead Sponsor
- Santerra Pharmaceuticals LLC (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1. Ambulatory adult patients of either sex >20 years of age
2. Patients with moderate osteoarthritis of the knee, clinically detected and/or diagnosed as per radiological examination and American Rhematology Association (ARA) functional classification
3. ARA functional class II or III
4. Kellgren Lawrence for knee osteoarthritis grade II, grade III
5. Patient's assessment of overall pain score between 40 and 100 mm on a pain-visual analogue scale after washout period
1. Arthritis other than osteoarthritis
2. Arthroscopy of either knee in the past year
3. Administration of intraarticular steroids within the past three months or hyaluronic acid in the last nine months
4. Known adverse responses to non-steroidal anti-inflammatory drugs (NSAIDs), suspected hypersensitivity, allergy or other contraindication to any compounds present in the study medication
5. Significant gastrointestinal (GI) diseases or previous GI upset to NSAID administration
6. Pregnant or lactating women or woman of child-bearing age not following adequate contraception
7. Evidence of severe renal, hematopoetic disease or severe cardiac insufficiency as revealed by laboratory investigations and other tests
8. Moderate to severe peripheral neuropathy or other neurological disorders
9. Unwilling or unable to come to regular follow-up studies
10. Any condition which in the opinion of the investigator does not justify patient inclusion in the study
11. Inability to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pain visual analogue score<br>2. Modified Western Ontario and McMaster University osteoarthritis index (WOMAC)
- Secondary Outcome Measures
Name Time Method 1. Serum insulin-like growth factor-1 (IGF-1)<br>2. Global assessment of therapy<br>3. Patient's opinion<br>4. Consumption of rescue medication