NCT03365388

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

December 2, 2017

Last Update Submit

December 6, 2017

Conditions

Periarthritis

Outcome Measures

Primary Outcomes (1)

  • Changes of Pain Rating Scale（NRS）

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

    Fifth weeks after medication

Secondary Outcomes (1)

  • The number of adverse events

    Fifth weeks after medication

Study Arms (2)

Sodium Hyaluronate group

EXPERIMENTAL

Treatment of periarthritis of shoulder with Sodium Hyaluronate

Drug: Sodium Hyaluronate

Aerzhi group

ACTIVE COMPARATOR

Treatment of periarthritis of shoulder with Aerzhi

Drug: Aerzhi

Interventions

Sodium HyaluronateDRUG

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

Sodium Hyaluronate group
AerzhiDRUG

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

Also known as: Sodium Hyaluronate Injection
Aerzhi group

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (9)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 20170770BACKGROUND

MeSH Terms

Conditions

Periarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesBursitis

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Peixun Zhang, Doctor

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Zhang, Doctor

CONTACT

0860108832655052956255@qq.com

Yichong Zhang, Doctor

CONTACT

08601088326550zhangyichong@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patient was diagnosed with periarthritis of shoulder
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 2, 2017

First Posted

December 7, 2017

Study Start

April 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

December 7, 2017

Record last verified: 2017-12

Locations

CN(1)