Open labeled clinical research on utility of pentosan polysulfate(pentosan) to osteoarthritis of the knee
- Conditions
- almost healthy with mild osteoarthritis of the knee
- Registration Number
- JPRN-UMIN000002790
- Lead Sponsor
- Pentosan Research Society
- Brief Summary
The dose of this pentosan affected the blood coagulation tests, but the value in the study was within a safe range. A tiny abnormal finding was noted in serum chemistry: i.e., serum triglyceride at one hour after injection, but it was reduced quickly in the follow-up period. The hydroarthroses were reduced quickly in all cases. The ROM of the knee joint improved significantly. The clinical assessments, i.e., knee flexion, pain at walking, pain just after a climb up and down stairs, pain just after ROM exercise all improved significantly. The concentration of C2C in the blood decreased significantly. The clinical benefits of this study continued for almost one year. There was a statistically significant improvement from the baseline score in knee pain as measured by VAS at the 11th, 15th, 24th, and 52nd weeks. These good results were thought to be due to the improvement of cartilage metabolism, synovium condition and anti-inflammatory function by pentosan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Patients who received previous intra-articular corticosteroid or another drug injection in the knee joint within the previous 3 months. 2. Patients who had other lower-extremity musculoskeletal disability or pain. 3. Patients who had pain exceeding 45 mm on a 100-mm visual analogue scale (VAS, 0- 100, 100 as worst pain) immediately following walking for 50 m. 4. Patients who had any bleeding tendency with anti-coagulant drugs (besides aspirin) having gastric or duodenal ulcer or with suspicion of alimentary tract bleeding. 5. Patients who had other severe disease or handicap (for example (i.e.), liver, kidney, and bone marrow). 6. Patients who had a past history of drug allergy. 7. Patients who were pregnant or were breastfeeding. 8. Patients who had difficulty providing us with information. 9. Patients who had difficulty with the informed consent. About using NSAIDs, the patients were not eliminated if they could have a two-week wash-out period before entering into this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method