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A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder

Primary Purpose

Periarthritis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Sodium Hyaluronate

Aerzhi

About this trial

This is an interventional treatment trial for Periarthritis

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Signs and symptoms were repeated for 12 weeks or more at the time of signing informed consent (12 weeks or more)
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
Fully informed consent signed voluntarily informed consent

Exclusion Criteria:

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
Patients who are not suitable for medical treatment (e.g. patients with surgical indications)
Patients who received opioids before the first study of the drug
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)
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)
Treatment of shoulder joint (bilateral or unilateral) with hyaluronic acid injection within 24 weeks before the first study of the drug
It is diagnosed as rheumatic disease
Patients unable to assess their clinical manifestations
Skin disease or skin infection around the injection site can cause the risk of injection infection
Severe heart disease, renal failure, hematologic diseases, or diabetes mellitus
There is a history of hypersensitivity to any component in the research drug (IMP)

Sites / Locations

Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sodium Hyaluronate group

Aerzhi group

Arm Description

Treatment of periarthritis of shoulder with Sodium Hyaluronate

Treatment of periarthritis of shoulder with Aerzhi

Outcomes

Primary Outcome Measures

Changes of Pain Rating Scale（NRS）

At fifth weeks, subjects reported changes in NRS pain scores compared to baseline

Secondary Outcome Measures

The number of adverse events

The number of adverse events：Abnormal laboratory examination results，symptoms or diseases

Full Information

NCT ID

NCT03365388

First Posted

December 2, 2017

Last Updated

December 6, 2017

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03365388

Brief Title

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

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2018 (Anticipated)

Primary Completion Date

April 1, 2020 (Anticipated)

Study Completion Date

April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The patient was diagnosed with periarthritis of shoulder

Masking

Outcomes Assessor

Masking Description

The evaluation of the subjects will be conducted by the blind researchers. The IMP administration of the subjects will be conducted by non blind researchers or legal staff authorized by the principal investigator (PI)

Allocation

Randomized

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sodium Hyaluronate group

Arm Type

Experimental

Arm Description

Treatment of periarthritis of shoulder with Sodium Hyaluronate

Arm Title

Aerzhi group

Arm Type

Active Comparator

Arm Description

Treatment of periarthritis of shoulder with Aerzhi

Intervention Type

Drug

Intervention Name(s)

Sodium Hyaluronate

Intervention Description

Hyaluronic acid is a component of synovial fluid. N- is glucuronic acid and N-acetylglucosamine repeating disaccharide unit form

Intervention Type

Drug

Intervention Name(s)

Aerzhi

Other Intervention Name(s)

Sodium Hyaluronate Injection

Intervention Description

Sodium Hyaluronate Injection can cover and protect joint tissue, improve lubrication function, and penetrate degenerative cartilage

Primary Outcome Measure Information:

Title

Changes of Pain Rating Scale（NRS）

Description

At fifth weeks, subjects reported changes in NRS pain scores compared to baseline

Time Frame

Fifth weeks after medication

Secondary Outcome Measure Information:

Title

The number of adverse events

Description

The number of adverse events：Abnormal laboratory examination results，symptoms or diseases

Time Frame

Fifth weeks after medication

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Signs and symptoms were repeated for 12 weeks or more at the time of signing informed consent (12 weeks or more) 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 Fully informed consent signed voluntarily informed consent Exclusion Criteria: 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 Patients who are not suitable for medical treatment (e.g. patients with surgical indications) Patients who received opioids before the first study of the drug 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) 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) Treatment of shoulder joint (bilateral or unilateral) with hyaluronic acid injection within 24 weeks before the first study of the drug It is diagnosed as rheumatic disease Patients unable to assess their clinical manifestations Skin disease or skin infection around the injection site can cause the risk of injection infection Severe heart disease, renal failure, hematologic diseases, or diabetes mellitus There is a history of hypersensitivity to any component in the research drug (IMP)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peng Zhang, Doctor

Phone

08601088326550

52956255@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yichong Zhang, Doctor

Phone

08601088326550

zhangyichong@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peixun Zhang, Doctor

Organizational Affiliation

Peking University People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University People's Hospital

City

Peking

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peixun Zhang, Doctor

Phone

08613611237628

zhangpeixun@163.com

First Name & Middle Initial & Last Name & Degree

Yichong Zhang, Doctor

Phone

08601088326550

zhangyichong@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

Citation

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.

Results Reference

background

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.

Results Reference

background

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.

Results Reference

background

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.

Results Reference

background

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.

Results Reference

background

Citation

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.

Results Reference

background

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

Results Reference

background

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.

Results Reference

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PubMed Identifier

20170770

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.

Results Reference

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A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder

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