PeriarthritisNCT03365388
A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder
A study testing Sodium Hyaluronate and Aerzhi in people with Periarthritis, run by Peking University People's Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Periarthritis
- What is being tested?
- Sodium Hyaluronate and Aerzhi
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Peixun Zhang, Doctor, 08613611237628, zhangpeixun@163.com
Yichong Zhang, Doctor, 08601088326550, zhangyichong@163.com
About this study
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
Read the 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
- Conditions
- Periarthritis
- Being tested
- Sodium Hyaluronate, Aerzhi
- Medical subject headings
- Periarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HyaluronateDrug
Hyaluronic acid is a component of synovial fluid. N- is glucuronic acid and N-acetylglucosamine repeating disaccharide unit form
AerzhiDrug
Also called Sodium Hyaluronate Injection
Sodium Hyaluronate Injection can cover and protect joint tissue, improve lubrication function, and penetrate degenerative cartilage
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hyaluronate group | Experimental | Treatment of periarthritis of shoulder with Sodium Hyaluronate Receives: Drug: Sodium Hyaluronate |
| Aerzhi group | Active comparator | Treatment of periarthritis of shoulder with Aerzhi Receives: Drug: Aerzhi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Pain Rating Scale（NRS）
At fifth weeks, subjects reported changes in NRS pain scores compared to baseline
Measured: Fifth weeks after medication
Secondary outcomes (1)
The number of adverse events
The number of adverse events：Abnormal laboratory examination results，symptoms or diseases
Measured: Fifth weeks after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Apr 2018 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PeriarthritisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patient was diagnosed with periarthritis of shoulder
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pengzhang, Peking University People's Hospital
- Investigators
- Peixun Zhang, Doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365388
- Sponsor's protocol ID
- CSG-trail201703
- Status last verified
- Dec 2017
- First submitted
- 2 Dec 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
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.
PubMed 20170770
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder
- ClinicalTrials.gov ID
- NCT03365388
- Acronym / sponsor ID
- CSG-trail201703
- Conditions
- Periarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patient was diagnosed with periarthritis of shoulder
| Arm | Type | Receives |
|---|---|---|
| Sodium Hyaluronate group | Experimental | Drug: Sodium HyaluronateTreatment of periarthritis of shoulder with Sodium Hyaluronate |
| Aerzhi group | Active comparator | Drug: AerzhiTreatment of periarthritis of shoulder with Aerzhi |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium HyaluronateHyaluronic acid is a component of synovial fluid. N- is glucuronic acid and N-acetylglucosamine repeating disaccharide unit form | Drug | Sodium Hyaluronate group |
| AerzhiAlso: Sodium Hyaluronate InjectionSodium Hyaluronate Injection can cover and protect joint tissue, improve lubrication function, and penetrate degenerative cartilage | Drug | Aerzhi group |
Primary outcome
Changes of Pain Rating Scale（NRS）
Time frame: Fifth weeks after medication
At fifth weeks, subjects reported changes in NRS pain scores compared to baseline
1 secondary outcome
The number of adverse events
Time frame: Fifth weeks after medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- BackgroundYamamoto 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.
- BackgroundKurokawa 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.
- BackgroundYamamoto 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.
- BackgroundYamamoto 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.
- BackgroundYamamoto 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.
- BackgroundTanaka 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.
- BackgroundTanaka 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
- BackgroundTanaka 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: PubMed 20170770Zhang 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peixun Zhang, Doctor principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Hyaluronate and Aerzhi in people with Periarthritis, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Zhang, Doctor (08601088326550, 52956255@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Pain Rating Scale（NRS） (time frame: Fifth weeks after medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03365388, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.