Knee OsteoarthritisPhase 4ArtzNCT02826031
Clinical Study of Artz in the Treatment of Knee Osteoarthritis
A Phase 4 study testing Sodium Hyaluronate Injection and DICL-SR in people with Knee Osteoarthritis, run by Kunming Baker Norton Pharmaceutical Sales Co., Ltd. at 6 sites in China.
Trial summary
This is a multi-center, randomized, open-label, parallel-arm phase IV clinical study, for which a total of 300 patients with mild to moderate knee osteoarthritis will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Sodium Hyaluronate Injection and DICL-SR
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 6 sitesChina
- Study dates
- Apr 2016to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Chinese subjects, at age≥18, either gender, diagnosed with osteoarthritis of the target knee and Kellgren-Lawrence (KL) classification Grade 1~3, as evidenced by X-ray examination in the last 3 months (mild to moderate narrowing of joint space and / or marked osteophytes of tibiofemoral joint space)
- Persist pain of the target knee after exercise, weight loss and physical therapy;
- A baseline WOMAC A1 score for the target knee rated at 40-90mm (moderate to severe walk-associated pain) on 100mm Visual analogue scale(VAS); Able to understand and sign the Informed Consent Form (ICF) that has already been approved by the Independent Ethics Committee (IEC) Note: the informed consent may also be given by the duly authorized representative of the subject.
Who cannot join
- A diagnosis of bilateral knee osteoarthritis;
- Clinically significant (requiring surgery) valgus or varus deformity of the knee joint, ligamentous laxity or unstable meniscus;
- Complicated by inflammation or any other disease /condition (e.g., rheumatic arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.) that may affect the knee joint;
- A history of septicemia, clinically considered sub-acute infection of the target knee joint;
- A history of surgery on the target knee (in the last 6 months);
- A history of asthma, urticaria or allergy after use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
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- Severe hepatic or renal disease or hepatic /renal failure;
- Any unscheduled surgery on the lower limb;
- Clinically significant lower venous or lymphatic obstruction;
- Clinically significant obvious exudation or inflammation of the target knee;
- Skin disorders or infection at the injection site;
- Pregnant or lactating women;
- Known allergy to guanylin and / or any active ingredient or excipient of hyaluronic acid-based injection / diclofenac sodium;
- Treatment with any hyaluronic acid (HA) or its derivatives for the target knee within six months before this trial;
- Intra-articular (IA) injection of steroids into the target knee within 3 months before this trial;
- Presence of any contraindication to IA injection, e.g., patients who are receiving anti-coagulation therapy or clinically have potential coagulation disorders (e.g., hepatic disease);
- Presence of any clinically significant disease (e.g., significant mental or nervous disorders, alcohol/drug abuse), unstable/poorly controlled diseases, or other factors, which may affect their evaluation or participation in this study in the investigator's judgment
- Perioperative pain associated with coronary artery bypass surgery (CABG);
- A history of gastrointestinal bleeding or perforation following use of NSAIDs;
- Presence of active gastrointestinal ulcer /bleeding, or a past history of recurrent ulcer/bleeding; Chief complaint complicated by pain beyond the target knee,
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 5 recruiting
- Active, not recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Wei Huang, Doctor, +86-13883383330
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Zhanjun Shi, Doctor, +86-13503037919
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Qing Jiang, Doctor, +86-13605192953
- Not yet recruiting
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 200235
Changqing Zhang, Doctor, +86-13003104089
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 409099
Kun Zheng Wang, Doctor, +86-13809195901, wkzh1955@163.com
About this study
Official title: A Multi-center, Randomized, Open-label, Parallel-arm Controlled Study Comparing Demand-based Monotherapy of Non-steroidal Anti-inflammatory Drug (NSAID) vs. Demand-based NSAID Combined With Sodium Hyaluronate Injection in the Treatment of Chinese Patients With Mild to Moderate Knee Osteoarthritis
This is a multi-center, randomized, open-label, parallel-arm phase IV clinical study, for which a total of 300 patients with mild to moderate knee osteoarthritis will be enrolled. In the first 4 weeks (run-in period), the subjects will receive on-demand treatment with Diclofenac Sodium Sustained Release Tablets (DICL-SR) 75mg, quaque die（QD）. After the run-in period, the subjects, if their knee pain has not worsened to a level requiring surgical treatment, will be randomized to two groups in 1:1 ratio: one group receiving Artz® via intra-articular injection (once weekly, for 5 consecutive weeks) in combination with DICL-SR 75mg,quaque die（QD）, for 12 consecutive weeks on demand. The other group receiving DICL-SR 75mg alone,quaque die（QD）, for 12 consecutive weeks on demand. DICL-SR 75mg quaque die（QD） may be administered to the subjects of both groups on demand as long as they have a knee pain. If the knee pain has disappeared, this drug may be withdrawn. However, if the pain occurs again and requires treatment, oral administration of DICL-SR may be resumed. A subject is allowed to withdraw from this study prematurely if unable to tolerate the adverse effects.
A total of 8 visits have been scheduled for this study, including Visit 1/screening period (Week -4), Visit 2/baseline (Week 0), Visit 3 (Week 1), Visit 4 (Week 2), Visit 5 (Week 3), Visit 6 (Week 4), Visit 7 (Week 8) and Visit 8 (Week 12).
A total of 300 subjects will participate in this study at 6 to 8 centers in China, and patient enrollment is expected to take up to 12 months.
- Conditions
- Knee Osteoarthritis
- Being tested
- Sodium Hyaluronate Injection, DICL-SR
- Keywords
- Sodium Hyaluronate, mild to moderate knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hyaluronate InjectionDrug
DICL-SRDrug
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hyaluronate Injection + DICL-SR | Experimental | Each syringe (2.5mL) contains 25mg of sodium hyaluronate, and one Artz® will be administered via intra-articular injection into the target knee at the baseline and Weeks 1, 2, 3 and 4 respectively for the combination group.
From the run-in period to the end of study, both groups will receive DICL-SR 75mg, which is administered on demand for treatment of knee pain. If the knee pain is relieved or has disappeared, DICL-SR may be withdrawn. However, if the pain occurs again and requires treatment, the drug may be resumed. If a dose of 75mg daily fails to control the knee pain, it may be increased to the maximum dose 150mg daily upon the approval of the investigator, that is, 75mg bis in die（BID） daily Receives: Drug: Sodium Hyaluronate Injection; Drug: DICL-SR |
| DICL-SR | Active comparator | From the run-in period to the end of study, both groups will receive Diclofenac Sodium Sustained-release Tablets(DICL-SR) 75mg, which is administered on demand for treatment of knee pain. If the knee pain is relieved or has disappeared, DICL-SR may be withdrawn. However, if the pain occurs again and requires treatment, the drug may be resumed. If a dose of 75mg daily fails to control the knee pain, it may be increased to the maximum dose 150mg daily upon the approval of the investigator, that is, 75mg bis in die（BID daily）. A subject is allowed to withdraw from this study prematurely if unable to tolerate the adverse effects. Receives: Drug: DICL-SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the average daily doses (unit: pills) of the NSAID from Week9 (W9) to W12 between two groups
Measured: From W9 to W12 (4 weeks)
Secondary outcomes (6)
Compare the average daily doses (unit: pills) of the NSAID from W5 to W8, and W5 to W12 between two groups
Measured: From W5 to W8 (4 weeks), and W5 to W12 (8 weeks)
Compare the changes in the average daily doses (unit: pills) of the NSAID at the 8th and 12th week from baseline between two groups.
Measured: At the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Compare the percentage changes in the average daily doses (unit: pills) of the NSAID at the 8th and 12th week from baseline between two groups.
Measured: At the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Compare the days of NSAID consumption from W5 to W8, W9 to W12, and W5 to W12 between two groups.
Measured: From W5 to W8 (4 weeks), W9 to W12 (4 weeks), and W5 to W12 (8 weeks)
Compare the changes in WOMAC A1 score (walk-associated pain), WOMAC A, B and C score and patient global assessment (PTGA) at the 4th, 8th and 12th week from baseline between two groups.
Measured: At the 4th week from baseline (1 week), at the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Compare the changes in clinical observer global assessment (COGA), and scores for activities of daily living (ADL) at the 4th, 8th and 12th week from baseline between two groups.
Measured: At the 4th week from baseline (1 week), at the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Baker Norton Pharmaceutical Sales Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kun Zheng WANG, Doctor, Study chair, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826031
- Sponsor's protocol ID
- ARTZ2013PMS01
- Acronym
- Artz
- Status last verified
- May 2017
- First submitted
- 27 Jun 2016
- Last updated
- 4 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Parallel-arm Controlled Study Comparing Demand-based Monotherapy of Non-steroidal Anti-inflammatory Drug (NSAID) vs. Demand-based NSAID Combined With Sodium Hyaluronate Injection in the Treatment of Chinese Patients With Mild to Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02826031
- Acronym / sponsor ID
- Artz / ARTZ2013PMS01
- Conditions
- Knee Osteoarthritis
- Keywords
- Sodium Hyaluronate, mild to moderate knee osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kunming Baker Norton Pharmaceutical Sales Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jul 2016 (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 is a multi-center, randomized, open-label, parallel-arm phase IV clinical study, for which a total of 300 patients with mild to moderate knee osteoarthritis will be enrolled. In the first 4 weeks (run-in period), the subjects will receive on-demand treatment with Diclofenac Sodium Sustained Release Tablets (DICL-SR) 75mg, quaque die（QD）. After the run-in period, the subjects, if their knee pain has not worsened to a level requiring surgical treatment, will be randomized to two groups in 1:1 ratio: one group receiving Artz® via intra-articular injection (once weekly, for 5 consecutive weeks) in combination with DICL-SR 75mg,quaque die（QD）, for 12 consecutive weeks on demand. The other group receiving DICL-SR 75mg alone,quaque die（QD）, for 12 consecutive weeks on demand. DICL-SR 75mg quaque die（QD） may be administered to the subjects of both groups on demand as long as they have a knee pain. If the knee pain has disappeared, this drug may be withdrawn. However, if the pain occurs again and requires treatment, oral administration of DICL-SR may be resumed. A subject is allowed to withdraw from this study prematurely if unable to tolerate the adverse effects.
A total of 8 visits have been scheduled for this study, including Visit 1/screening period (Week -4), Visit 2/baseline (Week 0), Visit 3 (Week 1), Visit 4 (Week 2), Visit 5 (Week 3), Visit 6 (Week 4), Visit 7 (Week 8) and Visit 8 (Week 12).
A total of 300 subjects will participate in this study at 6 to 8 centers in China, and patient enrollment is expected to take up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Hyaluronate Injection + DICL-SR | Experimental | Drug: Sodium Hyaluronate Injection, Drug: DICL-SREach syringe (2.5mL) contains 25mg of sodium hyaluronate, and one Artz® will be administered via intra-articular injection into the target knee at the baseline and Weeks 1, 2, 3 and 4 respectively for the combination group. From the run-in period to the end of study, both groups will receive DICL-SR 75mg, which is administered on demand for treatment of knee pain. If the knee pain is relieved or has disappeared, DICL-SR may be withdrawn. However, if the pain occurs again and requires treatment, the drug may be resumed. If a dose of 75mg daily fails to control the knee pain, it may be increased to the maximum dose 150mg daily upon the approval of the investigator, that is, 75mg bis in die（BID） daily |
| DICL-SR | Active comparator | Drug: DICL-SRFrom the run-in period to the end of study, both groups will receive Diclofenac Sodium Sustained-release Tablets(DICL-SR) 75mg, which is administered on demand for treatment of knee pain. If the knee pain is relieved or has disappeared, DICL-SR may be withdrawn. However, if the pain occurs again and requires treatment, the drug may be resumed. If a dose of 75mg daily fails to control the knee pain, it may be increased to the maximum dose 150mg daily upon the approval of the investigator, that is, 75mg bis in die（BID daily）. A subject is allowed to withdraw from this study prematurely if unable to tolerate the adverse effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Chinese subjects, at age≥18, either gender, diagnosed with osteoarthritis of the target knee and Kellgren-Lawrence (KL) classification Grade 1~3, as evidenced by X-ray examination in the last 3 months (mild to moderate narrowing of joint space and / or marked osteophytes of tibiofemoral joint space)
- Persist pain of the target knee after exercise, weight loss and physical therapy;
- A baseline WOMAC A1 score for the target knee rated at 40-90mm (moderate to severe walk-associated pain) on 100mm Visual analogue scale(VAS); Able to understand and sign the Informed Consent Form (ICF) that has already been approved by the Independent Ethics Committee (IEC) Note: the informed consent may also be given by the duly authorized representative of the subject.
Key exclusion criteria (20 listed)
- A diagnosis of bilateral knee osteoarthritis;
- Clinically significant (requiring surgery) valgus or varus deformity of the knee joint, ligamentous laxity or unstable meniscus;
- Complicated by inflammation or any other disease /condition (e.g., rheumatic arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.) that may affect the knee joint;
- A history of septicemia, clinically considered sub-acute infection of the target knee joint;
- A history of surgery on the target knee (in the last 6 months);
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 Hyaluronate Injection | Drug | Sodium Hyaluronate Injection + DICL-SR |
| DICL-SR | Drug | DICL-SR, Sodium Hyaluronate Injection + DICL-SR |
Primary outcome
Compare the average daily doses (unit: pills) of the NSAID from Week9 (W9) to W12 between two groups
Time frame: From W9 to W12 (4 weeks)
6 secondary outcomes
Compare the average daily doses (unit: pills) of the NSAID from W5 to W8, and W5 to W12 between two groups
Time frame: From W5 to W8 (4 weeks), and W5 to W12 (8 weeks)
Compare the changes in the average daily doses (unit: pills) of the NSAID at the 8th and 12th week from baseline between two groups.
Time frame: At the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Compare the percentage changes in the average daily doses (unit: pills) of the NSAID at the 8th and 12th week from baseline between two groups.
Time frame: At the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Compare the days of NSAID consumption from W5 to W8, W9 to W12, and W5 to W12 between two groups.
Time frame: From W5 to W8 (4 weeks), W9 to W12 (4 weeks), and W5 to W12 (8 weeks)
Compare the changes in WOMAC A1 score (walk-associated pain), WOMAC A, B and C score and patient global assessment (PTGA) at the 4th, 8th and 12th week from baseline between two groups.
Time frame: At the 4th week from baseline (1 week), at the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Compare the changes in clinical observer global assessment (COGA), and scores for activities of daily living (ADL) at the 4th, 8th and 12th week from baseline between two groups.
Time frame: At the 4th week from baseline (1 week), at the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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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.
Kun Zheng WANG, Doctor study chair
Second Affiliated Hospital of Xi'an Jiaotong University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Hyaluronate Injection and DICL-SR in people with Knee Osteoarthritis, run by Kunming Baker Norton Pharmaceutical Sales Co., Ltd. at 6 sites 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 3 inclusion and 20 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 YA NAN TANG, Master (+86-21-33278388 ext. 211, annie_tyn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the average daily doses (unit: pills) of the NSAID from Week9 (W9) to W12 between two groups (time frame: From W9 to W12 (4 weeks)). 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 4 May 2017.