Medical Chitosan or Sodium Hyaluronate for Knee Osteoarthritis (CHOOSE)

NCT02323451 | Unknown Phase 4 DMC

• 1 other identifier: QS20140506
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  six weeks of the initial injection

Secondary Outcomes (1)

• WOMAC for knee pain

  six weeks of the initial injection

Study Arms (2)

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

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.

Drug: Sodium Hyaluronate Injection

Interventions

Medical Chitosan DEVICE

intra-articular injection

Medical Chitosan

Sodium Hyaluronate Injection DRUG

intra-articular injection

Sodium Hyaluronate Injection

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Qisheng Biological Preparation Co., Ltd.: lead

Study Sites (1)

Shanghai Sixth People's Hospital. Orthopedics.

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Changqing Zhang, PhD

  Shanghai,China.Shanghai Sixth People's Hospital. Orthopedics. Recruiting. No. 600. Yishan Rd. Shanghai. Post Code:200233.

  PRINCIPAL INVESTIGATOR

• Shigui Yan, PhD

  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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changqing Zhang, PhD

CONTACT

+86-13003104089; zhangcq@sjtu.edu.cn

Shengbao Chen, MD

CONTACT

+86-18930172088; shengbaocheng@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: April 1, 2017
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

CN (1)