Back to resultsSinomenine Versus Glucocorticoid for Knee OA
Primary Purpose
Knee Osteoarthritis
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sinomenine
Glucocorticoid
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria: Age > 40 and <70. Bilateral knee pain lasting for more than 6 months and most of the last month; X-rays showed that Kellgren and Lawrence had grade 2 or 3 knee osteoarthritis. Exclusion Criteria: Kellgren and Lawrence Level 1 or 4. Radiographs showed that the reduction of the lateral joint space was greater than or equal to the medial joint space. The affected knee had been injected with glucocorticoid or hyaluronic acid within the past 6 months. Have had knee surgery or plan to have joint surgery on the affected knee. Other medical conditions such as: systemic or inflammatory joint diseases (rheumatoid arthritis), history of crystalline or neurological joints, other muscular, joint or nervous system diseases affecting lower limb function. Have a needle phobia. Immunosuppression or acute infection is present. Patients are allergic to the drugs involved in the study. Have or have had cancer or tumours. Have a hemorrhagic disease or are receiving anticoagulant or antiplatelet therapy. History of hyperlipidemia, or plasma total cholesterol ≥6.2mmol/L and triglycerides >2.3mmol/L Have any other medical conditions that do not participate in the study, including contraindications to MRI, such as pacemakers. Pregnancy. Body mass Index (BMI) > 40 kg/m2. Unable to attend all study appointments within 24 months; Inability to understand written and spoken Chinese. Any history of mental and psychological illness.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sinomenine
Glucocorticoid
Arm Description
Outcomes
Primary Outcome Measures
total WOMAC score and tibial cartilage volume
24 months after the first injection (1) the change in the total WOMAC score from baseline and whether sinomenine was noninferior to glucocorticoid, and (2) the change in tibial cartilage volume from baseline (on average thickness in mm) and whether sinomenine was noninferior to glucocorticoid.
Secondary Outcome Measures
The Timed Up and Go and 20m walking time
24 months after the first injection (1) the change in time from baseline in The Timed Up and Go (TUG) test and whether sinomenine was noninferior to glucocorticoid, and (2) the change in time spent at 20m walking time from baseline was and whether sinomenine was noninferior to glucocorticoid.
Full Information
NCT ID
NCT05764304
First Posted
February 17, 2023
Last Updated
March 1, 2023
Sponsor
Shanghai 6th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05764304
Brief Title
Sinomenine Versus Glucocorticoid for Knee OA
Official Title
Therapeutic Evaluation of Treatment With Sinomenine Versus Glucocorticoid for Early Knee Osteoarthritis: A Prospective, Double-Blind, Randomized, Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 28, 2023 (Anticipated)
Primary Completion Date
February 27, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Both glucocorticoid and sinomenine are widely used in the routine clinical treatment of osteoarthritis, but there is still a lack of high level of clinical evidence for the direct comparison of efficacy between the two drugs. This trial aims to evaluate whether intraarticular injection of sinomenine was noninferior to intraarticular injection of glucocorticoid for symptom relief in patients with early knee arthritis, and whether intraarticular injection of sinomenine was superior to intraarticular injection of glucocorticoid for changes in tibial cartilage volume (measured by mean thickness) from baseline compared with intraarticular injection of glucocorticoid. 326 people will participate in the study at 3 different research/medical institutions, with centres competing for inclusion. This trial was designed by random blind method. This trial will last for 2 years and participants will receive 6 injections every 4 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sinomenine
Arm Type
Experimental
Arm Title
Glucocorticoid
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sinomenine
Intervention Description
Participants will receive one intra-articular injection every 4 months
Intervention Type
Drug
Intervention Name(s)
Glucocorticoid
Intervention Description
Participants will receive one intra-articular injection every 4 months
Primary Outcome Measure Information:
Title
total WOMAC score and tibial cartilage volume
Description
24 months after the first injection (1) the change in the total WOMAC score from baseline and whether sinomenine was noninferior to glucocorticoid, and (2) the change in tibial cartilage volume from baseline (on average thickness in mm) and whether sinomenine was noninferior to glucocorticoid.
Time Frame
24 months after the first injection
Secondary Outcome Measure Information:
Title
The Timed Up and Go and 20m walking time
Description
24 months after the first injection (1) the change in time from baseline in The Timed Up and Go (TUG) test and whether sinomenine was noninferior to glucocorticoid, and (2) the change in time spent at 20m walking time from baseline was and whether sinomenine was noninferior to glucocorticoid.
Time Frame
24 months after the first injection
Other Pre-specified Outcome Measures:
Title
Bone marrow lesion (BML)
Description
12 and 24 months after the first injection, to evaluate bone marrow lesion (BML) size of patients and whether sinomenine was noninferior to glucocorticoid.
Time Frame
12 and 24 months after the first injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 40 and <70.
Bilateral knee pain lasting for more than 6 months and most of the last month;
X-rays showed that Kellgren and Lawrence had grade 2 or 3 knee osteoarthritis.
Exclusion Criteria:
Kellgren and Lawrence Level 1 or 4.
Radiographs showed that the reduction of the lateral joint space was greater than or equal to the medial joint space.
The affected knee had been injected with glucocorticoid or hyaluronic acid within the past 6 months.
Have had knee surgery or plan to have joint surgery on the affected knee.
Other medical conditions such as: systemic or inflammatory joint diseases (rheumatoid arthritis), history of crystalline or neurological joints, other muscular, joint or nervous system diseases affecting lower limb function.
Have a needle phobia.
Immunosuppression or acute infection is present.
Patients are allergic to the drugs involved in the study.
Have or have had cancer or tumours.
Have a hemorrhagic disease or are receiving anticoagulant or antiplatelet therapy.
History of hyperlipidemia, or plasma total cholesterol ≥6.2mmol/L and triglycerides >2.3mmol/L
Have any other medical conditions that do not participate in the study, including contraindications to MRI, such as pacemakers.
Pregnancy.
Body mass Index (BMI) > 40 kg/m2.
Unable to attend all study appointments within 24 months;
Inability to understand written and spoken Chinese.
Any history of mental and psychological illness.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Sinomenine Versus Glucocorticoid for Knee OA
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