JPRN-jRCT2031230458
Recruiting
Phase 1
A phase 1b, parallel-group, observer-blind, 2-arm, 2-dose study to investigate the safety and tolerability of intravenous S-151128 compared with placebo in male and female participants aged 40 to 75 with knee osteoarthritis
Juan Carlos Gomez0 sites74 target enrollmentNovember 19, 2023
Conditionspatients with knee osteoarthritis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- patients with knee osteoarthritis
- Sponsor
- Juan Carlos Gomez
- Enrollment
- 74
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant aged 40 to 75 years, inclusive, at the time of signing the informed consent.
- •Participants with knee osteoarthritis who meet the American College of Rheumatology classification criteria for idiopathic knee osteoarthritis and have the disease duration of \>\=3 months
Exclusion Criteria
- •Current serious or medically unstable cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or clinically significant abnormal laboratory test results or electrocardiogram findings, capable of constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.
- •Concurrent malignant tumor requiring treatment or a history of malignant tumor within the past 5 years.
- •Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post\-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A \[IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- •Previously exposure to S\-151128\.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A Phase IIb, double-blind, parallel group, multi-centre, dose-finding study to investigate the efficacy and safety of 4 doses of MP-513 when added to ongoing metformin monotherapy in subjects with Type 2 diabetes mellitus, with an open label extensioType 2 diabetes mellitusMedDRA version: 13.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2008-008732-84-DKMitsubishi Tanabe Pharma Corporation400
Active, not recruiting
Not Applicable
A study to investigate the efficacy and safety of 4 doses of MP-513 in combination with metformin in patients with type 2 diabetesEUCTR2008-008732-84-DEMitsubishi Tanabe Pharma Corporation448
Active, not recruiting
Not Applicable
A Phase IIb, double-blind, parallel group, multi-centre, dose-finding study to investigate the efficacy and safety of 4 doses of MP-513 when added to ongoing metformin monotherapy in subjects with Type 2 diabetes mellitus, with an open label extensioEUCTR2008-008732-84-HUMitsubishi Tanabe Pharma Corporation400
Active, not recruiting
Not Applicable
A Phase IIb, double-blind, parallel group, multi-centre, dose-finding study to investigate the efficacy and safety of 4 doses of MP-513 when added to ongoing metformin monotherapy in subjects with Type 2 diabetes mellitus, with an open label extensioEUCTR2008-008732-84-GBMitsubishi Tanabe Pharma Corporation448
Active, not recruiting
Not Applicable
A Phase IIb, double-blind, parallel group, multi-centre, dose-finding study to investigate the efficacy and safety of 4 doses of MP-513 when added to ongoing metformin monotherapy in subjects with Type 2 diabetes mellitus, with an open label extensioType 2 diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlEUCTR2008-008732-84-LTMitsubishi Tanabe Pharma Corporation448