Osteoarthritis, KneePhase 4NCT02323451
Medical Chitosan or Sodium Hyaluronate for Knee Osteoarthritis (CHOOSE)
A Phase 4 study testing Medical Chitosan and Sodium Hyaluronate Injection in people with Osteoarthritis, Knee, run by Shanghai Qisheng Biological Preparation Co., Ltd. at 1 site in China.
Trial summary
This study evaluates the safety and efficacy of investigational products in the treatment of knee Osteoarthritis. Half of participants will receive medical chitosan, while the other half will receive sodium hyaluronate. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Medical Chitosan and Sodium Hyaluronate Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Apr 2017
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females at the age of 40-75 years old
- Conforming to the diagnosis standard of the American College of Rheumatology in 2009： knee pain and osteophyte determined with X-ray, and at least one of the following items：
- above 50 years old
- morning stiffness less than 30 minutes
- knee joint with fricative when moving
- The studying knee has score of 40-90 mm on a 100 mm measured VAS and the other side was less than 40mm when walking on flat ground.
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- The studying knee has score of 1, 2 or 3 determined by radiological Kellgren-Lawrence grading scale.
- Patients who have treatment requirements and can obey the therapeutic schedule
- Body mass index(BMI) ≤35kg/m2。
- Able to follow the clinical observation and follow up.
- The subjects are able to understand and sign the informed consent after fully understand this study, the disease, investigational drugs, the therapeutic schedule and the potential risks.
Who cannot join
- Positive signs of swelling or floating patella test，and there are obvious effusion of knee joint in clinical.
- Other inflammatory pain diseases of knee joint, such as rheumatism/ rheumatoid arthritis, psoriatic arthritis, gout, hemophilic arthritis, etc.
- Pain diseases of knee joint, except for osteoarthritis, such as intra-articular tumor, villonodular synovitis, joint trauma, etc.
- Pregnant or lactating females.
- Participants who suffer from serious cardiovascular disease (Sudden cerebral infarction with sequela or myocardial infarction within recent 6 months), hepatic disease, kidney disease；Participants whose ALT and AST are twice or more than twice than that of the upper limit of normal value；Participants whose serum creatinine exceed the upper limit of normal value；Participants who suffer from dysfunction of blood coagulation (thrombocytopenia, bleeder disease, etc.)
- Participants who have systemic infection or infectious disease.
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- Participants who suffer from serious skin defect or ulcer around the studying knee joint.
- Participants who suffer from typical varus or valgus deformities or lack of articular cavity.
- Participants with diabetes and have to inject insulin or who are not good enough to control the blood glucose (FBG ( fasting blood-glucose) ≥10mmol/L.)
- Participants who suffer from cancer (within 5 years) or Alzheimer's disease.
- Participants with score 0 or 4 of the studying knee joint evaluated by radiological Kellgren-Lawrence grading scale.
- Participants who have hormone drugs within 2 weeks or analgesic drugs within 1 week before this trial or take part in other clinical trials.
- Participants whose studying knee receives articular cavity therapy within 3 months, containing intra articular administration, articular irrigation and arthroscopic surgery
- Participants with an allergy to the experimental drugs.
- Participants who are not suitable for this trial judged by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital. Orthopedics.
Shanghai, Shanghai Municipality, 200233
Changqing Zhang, PhD, +86-13003104089, zhangcq@sjtu.edu.cn
Shengbao Chen, MD, +86-18930172088, shengbaocheng@163.com
About this study
Official title: A Multicentre, Randomized, Double-blinded, Parallel-controlled, Non-inferiority Clinical Study Of Safety and Efficacy Of Medical Chitosan for Knee Osteoarthritis Compared With Sodium Hyaluronate Injection
This study evaluates the safety and efficacy of investigational products in the treatment of knee Osteoarthritis. Half of participants will receive medical chitosan, while the other half will receive sodium hyaluronate.
Read the detailed description
Medical chitosan and sodium hyaluronate each form the reticular layer to cover the joint surface, alleviate the joint friction and pain. For medical chitosan, its half-life is longer than sodium hyaluronate, so the interval time of intra-articular injection is longer.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Medical Chitosan, Sodium Hyaluronate Injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical ChitosanDevice
intra-articular injection
Sodium Hyaluronate InjectionDrug
intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Medical Chitosan | Experimental | Medical Chitosan, 2ml/vial (12mg/ml), intra-articular injection with a volume less than 2ml every two weeks, a total of 3 times Receives: Device: Medical Chitosan |
| Sodium Hyaluronate Injection | Active comparator | Sodium Hyaluronate Injection, 2ml/vial (10mg/ml), intra-articular injection with a volume less than 2ml every one weeks, a total of 5 times. Receives: Drug: Sodium Hyaluronate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for knee pain
The investigator and the subject both evaluate the pain intensity per VAS before injection. VAS ranges from o to 10, 0=no pain, 10=pain as bad as can be.
Measured: six weeks of the initial injection
Secondary outcomes (1)
WOMAC for knee pain
WOMAC includes 3 items: pain, stiff and physiological function. 0=no, 4=as bad as can be.
Measured: six weeks of the initial injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Qisheng Biological Preparation Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changqing Zhang, PhD, Principal investigator, Shanghai,China.Shanghai Sixth People's Hospital. Orthopedics. Recruiting. No. 600. Yishan Rd. Shanghai. Post Code:200233.Shigui Yan, PhD, Principal investigator, Hangzhou,Chian. The Second Affiliated Hospital of Zhejiang University School of Medicine. Orthopedics. Not yet recruiting. No.88 Jiefang Road Hangzhou.China Post Code：310009
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323451
- Sponsor's protocol ID
- QS20140506
- Status last verified
- Dec 2014
- First submitted
- 18 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blinded, Parallel-controlled, Non-inferiority Clinical Study Of Safety and Efficacy Of Medical Chitosan for Knee Osteoarthritis Compared With Sodium Hyaluronate Injection
- ClinicalTrials.gov ID
- NCT02323451
- Acronym / sponsor ID
- QS20140506
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Shanghai Qisheng Biological Preparation Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 23 Dec 2014 (estimated)
- 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.
This study evaluates the safety and efficacy of investigational products in the treatment of knee Osteoarthritis. Half of participants will receive medical chitosan, while the other half will receive sodium hyaluronate.
Detailed description
Medical chitosan and sodium hyaluronate each form the reticular layer to cover the joint surface, alleviate the joint friction and pain. For medical chitosan, its half-life is longer than sodium hyaluronate, so the interval time of intra-articular injection is longer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Chitosan | Experimental | Device: Medical ChitosanMedical Chitosan, 2ml/vial (12mg/ml), intra-articular injection with a volume less than 2ml every two weeks, a total of 3 times |
| Sodium Hyaluronate Injection | Active comparator | Drug: Sodium Hyaluronate InjectionSodium Hyaluronate Injection, 2ml/vial (10mg/ml), intra-articular injection with a volume less than 2ml every one weeks, a total of 5 times. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females at the age of 40-75 years old
- Conforming to the diagnosis standard of the American College of Rheumatology in 2009： knee pain and osteophyte determined with X-ray, and at least one of the following items：
- The studying knee has score of 40-90 mm on a 100 mm measured VAS and the other side was less than 40mm when walking on flat ground.
- The studying knee has score of 1, 2 or 3 determined by radiological Kellgren-Lawrence grading scale.
- Patients who have treatment requirements and can obey the therapeutic schedule
Key exclusion criteria (15 listed)
- Positive signs of swelling or floating patella test，and there are obvious effusion of knee joint in clinical.
- Other inflammatory pain diseases of knee joint, such as rheumatism/ rheumatoid arthritis, psoriatic arthritis, gout, hemophilic arthritis, etc.
- Pain diseases of knee joint, except for osteoarthritis, such as intra-articular tumor, villonodular synovitis, joint trauma, etc.
- Pregnant or lactating females.
- Participants who suffer from serious cardiovascular disease (Sudden cerebral infarction with sequela or myocardial infarction within recent 6 months), hepatic disease, kidney disease；Participants whose ALT and AST are twice or more than twice than that of the upper limit of normal value；Participants whose serum creatinine exceed the upper limit of normal value；Participants who suffer from dysfunction of blood coagulation (thrombocytopenia, bleeder disease, etc.)
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 |
|---|---|---|
| Medical Chitosanintra-articular injection | Device | Medical Chitosan |
| Sodium Hyaluronate Injectionintra-articular injection | Drug | Sodium Hyaluronate Injection |
Primary outcome
Visual Analogue Scale for knee pain
Time frame: six weeks of the initial injection
The investigator and the subject both evaluate the pain intensity per VAS before injection. VAS ranges from o to 10, 0=no pain, 10=pain as bad as can be.
1 secondary outcome
WOMAC for knee pain
Time frame: six weeks of the initial injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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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.
Changqing Zhang, PhD principal investigator
Shanghai,China.Shanghai Sixth People's Hospital. Orthopedics. Recruiting. No. 600. Yishan Rd. Shanghai. Post Code:200233.
Shigui Yan, PhD principal investigator
Hangzhou,Chian. The Second Affiliated Hospital of Zhejiang University School of Medicine. Orthopedics. Not yet recruiting. No.88 Jiefang Road Hangzhou.China Post Code：310009
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medical Chitosan and Sodium Hyaluronate Injection in people with Osteoarthritis, Knee, run by Shanghai Qisheng Biological Preparation Co., Ltd. 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 11 inclusion and 15 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 24 Dec 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Changqing Zhang, PhD (+86-13003104089, zhangcq@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for knee pain (time frame: six weeks of the initial injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2014.