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A Trial of HRF2105 Patch in Relieving Pain of Osteoarthritis

Primary Purpose

Analgesia and Anti-inflammatory of Osteoarthritis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HRF2105 patch
Loxoprofen patch
placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia and Anti-inflammatory of Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able and willing to provide a written informed consent Male or female Meeting the diagnostic criteria of knee Articular bone osteoarthritis The target knee joint meeting the VAS scoring requirements K-L grading II-III,and the other knee joint grading is not higher than the target side Able to walk without assistance Willing to take contraceptive measures, female non pregnancy or lactation period Exclusion Criteria: Concomitant bronchial asthma; Previous aspirin induced asthma (non steroidal anti-inflammatory drugs induced asthma) Active or high-risk bleeding diseases such as gastrointestinal ulcers may worsen due to the use of NSAIDs Have a history of myocardial infarction or undergo coronary artery bypass grafting surgery Having serious cardiovascular, cerebrovascular, hematopoietic, metabolic system diseases or malignant tumors, as determined by the researcher, it is not suitable to participate in this study The combination of mental illnesses such as depression, dementia, and schizophrenia has been determined by researchers to affect the efficacy evaluation of study drugs Arthritis caused by other factors such as dermatomyositis, gouty arthritis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, purulent arthritis, systemic lupus erythematosus In addition to the knee joint, complications such as goose foot bursitis, intermittent claudication, and other conditions that can cause pain in the knee joint area Severe osteoarthritis with obvious narrowing of joint space and indications for surgery Pain in other areas that affect the evaluation of bone and joint pain, such as hip joint pain or lower back pain Rashes and skin damage on the intended application of the study drug Abnormal liver and kidney function, anemia or thrombocytopenia Within one year prior to signing the ICF, either side of the knee joint experienced open knee injury or underwent other knee joint surgeries such as arthroscopy, arthroscopic debridement, knee replacement, etc Patients who have received intra-articular drug injection therapy (such as glucocorticoids, sodium hyaluronate, medical chitosan, growth factors, and platelet rich plasma) on either side of the knee joint within 3 months prior to signing the ICF Within the first 5 days of randomization or during the study period, other drugs for treating osteoarthritis need to be used except the study drug During the research process, physical therapy and rehabilitation therapy for the lower limbs or waist are required Individuals with a history of allergies or contraindications to any component of this product or other losoprofen sodium preparations During this period, alcohol, drugs, and drug withdrawal may affect the effectiveness and safety evaluation of the study drug Participants in other clinical trials within 3 months Family members of the subjects in this study (cohabiting) Clinical research center employees directly involved in the operation, management, or support of this trial, or immediate family members Other situations that the researcher determines are not suitable for participating in this clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    HRF2105 patch

    Loxoprofen patch

    placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in VAS score from baseline at the end of treatment Day7 on rising from the chair

    Secondary Outcome Measures

    Change in WOMAC pain score from baseline at the end of treatment (Day7)
    Change in WOMAC stiffness score from baseline at the end of treatment (Day7)
    Change in WOMAC daily activity score from baseline at the end of treatment (Day7)
    Change in WOMAC total score from baseline at the end of treatment (Day7)
    Daily average dose of remedial drug (Paracetamol) during the treatment period
    Researcher satisfaction score
    Subject satisfaction score
    Skin irritation and sensitization scores

    Full Information

    First Posted
    September 14, 2023
    Last Updated
    September 14, 2023
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06047483
    Brief Title
    A Trial of HRF2105 Patch in Relieving Pain of Osteoarthritis
    Official Title
    A Multicenter, Randomized, Single Blind, Positive Drug and Placebo Parallel Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRF2105patch in Relieving Pain of Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The study is being conducted to evaluate the efficacy, and safety of HRF2105patch in relieving pain of Osteoarthritis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Analgesia and Anti-inflammatory of Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HRF2105 patch
    Arm Type
    Experimental
    Arm Title
    Loxoprofen patch
    Arm Type
    Active Comparator
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    HRF2105 patch
    Intervention Description
    HRF2105 patch ,external use,once a day
    Intervention Type
    Drug
    Intervention Name(s)
    Loxoprofen patch
    Intervention Description
    Loxoprofen patch ,external use,once a day
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo ,external use,once a day
    Primary Outcome Measure Information:
    Title
    Change in VAS score from baseline at the end of treatment Day7 on rising from the chair
    Time Frame
    Day7
    Secondary Outcome Measure Information:
    Title
    Change in WOMAC pain score from baseline at the end of treatment (Day7)
    Time Frame
    Day7
    Title
    Change in WOMAC stiffness score from baseline at the end of treatment (Day7)
    Time Frame
    Day7
    Title
    Change in WOMAC daily activity score from baseline at the end of treatment (Day7)
    Time Frame
    Day7
    Title
    Change in WOMAC total score from baseline at the end of treatment (Day7)
    Time Frame
    Day7
    Title
    Daily average dose of remedial drug (Paracetamol) during the treatment period
    Time Frame
    Day0-Day7
    Title
    Researcher satisfaction score
    Time Frame
    Day7
    Title
    Subject satisfaction score
    Time Frame
    Day7
    Title
    Skin irritation and sensitization scores
    Time Frame
    Day0-Day7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able and willing to provide a written informed consent Male or female Meeting the diagnostic criteria of knee Articular bone osteoarthritis The target knee joint meeting the VAS scoring requirements K-L grading II-III,and the other knee joint grading is not higher than the target side Able to walk without assistance Willing to take contraceptive measures, female non pregnancy or lactation period Exclusion Criteria: Concomitant bronchial asthma; Previous aspirin induced asthma (non steroidal anti-inflammatory drugs induced asthma) Active or high-risk bleeding diseases such as gastrointestinal ulcers may worsen due to the use of NSAIDs Have a history of myocardial infarction or undergo coronary artery bypass grafting surgery Having serious cardiovascular, cerebrovascular, hematopoietic, metabolic system diseases or malignant tumors, as determined by the researcher, it is not suitable to participate in this study The combination of mental illnesses such as depression, dementia, and schizophrenia has been determined by researchers to affect the efficacy evaluation of study drugs Arthritis caused by other factors such as dermatomyositis, gouty arthritis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, purulent arthritis, systemic lupus erythematosus In addition to the knee joint, complications such as goose foot bursitis, intermittent claudication, and other conditions that can cause pain in the knee joint area Severe osteoarthritis with obvious narrowing of joint space and indications for surgery Pain in other areas that affect the evaluation of bone and joint pain, such as hip joint pain or lower back pain Rashes and skin damage on the intended application of the study drug Abnormal liver and kidney function, anemia or thrombocytopenia Within one year prior to signing the ICF, either side of the knee joint experienced open knee injury or underwent other knee joint surgeries such as arthroscopy, arthroscopic debridement, knee replacement, etc Patients who have received intra-articular drug injection therapy (such as glucocorticoids, sodium hyaluronate, medical chitosan, growth factors, and platelet rich plasma) on either side of the knee joint within 3 months prior to signing the ICF Within the first 5 days of randomization or during the study period, other drugs for treating osteoarthritis need to be used except the study drug During the research process, physical therapy and rehabilitation therapy for the lower limbs or waist are required Individuals with a history of allergies or contraindications to any component of this product or other losoprofen sodium preparations During this period, alcohol, drugs, and drug withdrawal may affect the effectiveness and safety evaluation of the study drug Participants in other clinical trials within 3 months Family members of the subjects in this study (cohabiting) Clinical research center employees directly involved in the operation, management, or support of this trial, or immediate family members Other situations that the researcher determines are not suitable for participating in this clinical trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qin Liu
    Phone
    +0518-82342973
    Email
    Qin.liu@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Trial of HRF2105 Patch in Relieving Pain of Osteoarthritis

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