Periarthritis Clinical Trial
Official title:
A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder
Alge as a positive control drug, in patients with periarthritis of shoulder, in a double-blind, controlled manner to study the safety and treatment of Sodium Hyaluronate
| Status | Not yet recruiting |
| Enrollment | 260 |
| Est. completion date | April 1, 2020 |
| Est. primary completion date | April 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years to 80 Years |
| Eligibility |
Inclusion Criteria: 1. Based on clinical symptoms and range of motion (ROM) limitation: abduction is not more than 135 degrees, external rotation is not more than 20 degrees or the maximum internal rotation arrives at the first lumbar spinous process (the tip of the patient can touch) to diagnose the patients with periarthritis of shoulder 2. Signs and symptoms were repeated for 12 weeks or more at the time of signing informed consent (12 weeks or more) 3. At zeroth weeks, according to the pain assessment scale (NRS, range: 0-10), the subjects' self rating pain score was no less than 5 points 4. Fully informed consent signed voluntarily informed consent Exclusion Criteria: 1. Lead to other diseases of shoulder disorders, such as acute rotator cuff tear, calcific tendinitis. If the diagnosis is necessary, the MRI scan is performed 2. Patients who are not suitable for medical treatment (e.g. patients with surgical indications) 3. Patients who received opioids before the first study of the drug 4. Patients who received the following or more treatment within 2 weeks before the first use of the drug(Bilateral or unilateral shoulder joint movement therapy/Treatment of periarthritis of shoulder with proprietary Chinese Medicine) 5. Patients who received the following or more treatment within 4 weeks before the first use of the drug(Corticosteroids were injected locally or bilaterally on either side of the shoulder or on the other side of the shoulder (bilateral or unilateral shoulder joint);Oral corticosteroids, suppositories or intravenous preparations for the treatment of glucocorticoids) 6. Treatment of shoulder joint (bilateral or unilateral) with hyaluronic acid injection within 24 weeks before the first study of the drug 7. It is diagnosed as rheumatic disease 8. Patients unable to assess their clinical manifestations 9. Skin disease or skin infection around the injection site can cause the risk of injection infection 10. Severe heart disease, renal failure, hematologic diseases, or diabetes mellitus 11. There is a history of hypersensitivity to any component in the research drug (IMP) |
| Country | Name | City | State |
|---|---|---|---|
| China | Peking University People's Hospital | Peking | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University People's Hospital |
China,
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Tanaka S, Sohen S, Yamamoto M, Komatsubara Y, Sugawara S, Matsubara T, et al. Additional analysis for a multi-center phase III comparative clinical study of high molecular hyaluronic acid (NRD101) on rheumatoid arthritis. Clinical rheumatology and related research 2000;12: 179-204
Yamamoto M. Sugawara S. Tsukamoto Y. Motegi M. Iwata H. Ryu J. et al. Clinical Evaluation of high molecule weight hyaluronate (NRD101) on osteoarthritis of the knee: a phase III comparative clinical study with ARTZ? as a clinical drug. Jpn Pharmacol Ther 1994;22:319-47.
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Yamamoto R, Tabata S, Mikasa M, Takagishi K, Nakajima M, Dose-range finding study of high molecule weight sodium hyaluronate (NRD101) on periarthritis scapulohumeralis: a multi-center, late phase II clinical study. Jpn Pharmacol Ther 1994;22:351-74.
Yamamoto R, Tabata S, Mikasa M, Takagishi K, Nakajima M, Phase 3 comperative clinical study of high molecular weight sodium hyaluronate (NRD101) with ARTZ? on periarthritis scapulohumeralis. Jpn Pharmacol Ther 1994;22:289-317.
Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes of Pain Rating Scale(NRS) | At fifth weeks, subjects reported changes in NRS pain scores compared to baseline | Fifth weeks after medication | |
| Secondary | The number of adverse events | The number of adverse events:Abnormal laboratory examination results,symptoms or diseases | Fifth weeks after medication |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01807962 -
Local Injection Under US Control in GTPS.
|
Phase 3 |