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

Study Overview

• Status: Unknown
• Conditions: Periarthritis
• Intervention / Treatment: Drug: Sodium Hyaluronate; Drug: Aerzhi

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

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sodium Hyaluronate group; Treatment of periarthritis of shoulder with Sodium Hyaluronate	Drug: Sodium Hyaluronate; Hyaluronic acid is a component of synovial fluid. N- is glucuronic acid and N-acetylglucosamine repeating disaccharide unit form
ACTIVE_COMPARATOR: Aerzhi group; Treatment of periarthritis of shoulder with Aerzhi	Drug: Aerzhi; Sodium Hyaluronate Injection can cover and protect joint tissue, improve lubrication function, and penetrate degenerative cartilage; Other Names: Sodium Hyaluronate Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Pain Rating Scale（NRS）	At fifth weeks, subjects reported changes in NRS pain scores compared to baseline	Fifth weeks after medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of adverse events	The number of adverse events：Abnormal laboratory examination results，symptoms or diseases	Fifth weeks after medication

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Peixun Zhang, Doctor, Peking University People's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Tanaka S, Sohen S, Yamamoto M, Komatsubara Y, Sugawara S, Matsubara T, Additional analysis for a multi-center phase II clinical study of high molecule hyaluronic acid (NRD101) on rheumatoid arthritis. Clinical rheumatology and related research 2000:12: 157-78.
• 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
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2018
• Primary Completion (ANTICIPATED): April 1, 2020
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: December 2, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (ACTUAL): December 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Bursitis; Periarthritis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: CSG-trail201703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No