Clinical trial NCT03365388: A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder
Official title: A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periarthritis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 260
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patient was diagnosed with periarthritis of shoulder
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Aerzhi 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. Once a week, continuous treatment for 5 weeks

Eligibility criteria: 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)

Primary outcomes:
measure: Changes of Pain Rating Scale（NRS）
timeFrame: Fifth weeks after medication
Secondary outcomes:
measure: The number of adverse events
timeFrame: Fifth weeks after medication
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Peixun Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kurokawa T, Oda H, Mikami Y, Katsumoto H, Clinical Evaluation of high Molecule Weight Sodium Hyaluronate (NRD101) on osteoarthritis of the knee: phase III long-term clinical study. Jpn Pharmacol Ther 1994;22:267-88.
citation: Yamamoto R, Tabata S, Mikasa M, Takagishi K, Clinical evaluation of high molecule sodium hyaluronate (NRD101) on periarthritis scapulohumeralis. Jpn Pharmacol Ther 1993;21:267-80.
citation: 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.
citation: 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.
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citation: 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
citation: Tanaka S, Sohen S, Yamamoto M, Komatsubara Y, Sugawara S, Matsubara T, Additional analysis for a multi-center, long-term clinical study of high molecule weight hyaluronic acid (NRD101) on rheumatoid arthritis. Clinical rheumatology and related research 2000;12:213-40.
citation: 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.