Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study of Artz in the Treatment of Knee Osteoarthritis (Artz)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02826031
Recruitment Status : Unknown
Verified May 2017 by Kunming Baker Norton Pharmaceutical Sales Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Kunming Baker Norton Pharmaceutical Sales Co., Ltd.

Brief 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. 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 If the knee pain has disappeared, this drug may be withdrawn.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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Sodium Hyaluronate Injection Drug: DICL-SR Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Sodium Hyaluronate Injection + DICL-SR

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

Drug: Sodium Hyaluronate Injection
Drug: DICL-SR
Active Comparator: DICL-SR
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.
Drug: DICL-SR



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]

Other Outcome Measures:
  1. Incidence of all adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: up to 16 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. Persist pain of the target knee after exercise, weight loss and physical therapy;
  3. 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.

Exclusion Criteria:

  1. A diagnosis of bilateral knee osteoarthritis;
  2. Clinically significant (requiring surgery) valgus or varus deformity of the knee joint, ligamentous laxity or unstable meniscus;
  3. 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;
  4. A history of septicemia, clinically considered sub-acute infection of the target knee joint;
  5. A history of surgery on the target knee (in the last 6 months);
  6. A history of asthma, urticaria or allergy after use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
  7. Severe hepatic or renal disease or hepatic /renal failure;
  8. Any unscheduled surgery on the lower limb;
  9. Clinically significant lower venous or lymphatic obstruction;
  10. Clinically significant obvious exudation or inflammation of the target knee;
  11. Skin disorders or infection at the injection site;
  12. Pregnant or lactating women;
  13. Known allergy to guanylin and / or any active ingredient or excipient of hyaluronic acid-based injection / diclofenac sodium;
  14. Treatment with any hyaluronic acid (HA) or its derivatives for the target knee within six months before this trial;
  15. Intra-articular (IA) injection of steroids into the target knee within 3 months before this trial;
  16. 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);
  17. 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
  18. Perioperative pain associated with coronary artery bypass surgery (CABG);
  19. A history of gastrointestinal bleeding or perforation following use of NSAIDs;
  20. Presence of active gastrointestinal ulcer /bleeding, or a past history of recurrent ulcer/bleeding; Chief complaint complicated by pain beyond the target knee,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826031


Contacts
Layout table for location contacts
Contact: YA NAN TANG, Master +86-21-33278388 ext 211 annie_tyn@163.com
Contact: Kun Zheng WANG, Doctor +86-29-87678326 wkzh1955@163.com

Locations
Layout table for location information
China, Beijing
Peking Union Medical College Hospital Active, not recruiting
Peking, Beijing, China, 100730
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, Chongqing, China, 400016
Contact: Wei Huang, Doctor    +86-13883383330      
China, Guangdong
Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Zhanjun Shi, Doctor    +86-13503037919      
China, Jiangsu
Nanjing Drum Tower Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210008
Contact: Qing Jiang, Doctor    +86-13605192953      
China, Shaanxi
The Second Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 409099
Contact: Kun Zheng Wang, Doctor    +86-13809195901    wkzh1955@163.com   
China, Shanghai
Shanghai 6th People's Hospital Not yet recruiting
Shanghai, Shanghai, China, 200235
Contact: Changqing Zhang, Doctor    +86-13003104089      
Sponsors and Collaborators
Kunming Baker Norton Pharmaceutical Sales Co., Ltd.
Investigators
Layout table for investigator information
Study Chair: Kun Zheng WANG, Doctor Second Affiliated Hospital of Xi'an Jiaotong University

Layout table for additonal information
Responsible Party: Kunming Baker Norton Pharmaceutical Sales Co., Ltd.
ClinicalTrials.gov Identifier: NCT02826031    
Other Study ID Numbers: ARTZ2013PMS01
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Keywords provided by Kunming Baker Norton Pharmaceutical Sales Co., Ltd.:
Sodium Hyaluronate
mild to moderate knee osteoarthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents