A Trial of HRF2105 Patch in Relieving Pain of Osteoarthritis

September 14, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. Male or female
  3. Meeting the diagnostic criteria of knee Articular bone osteoarthritis
  4. The target knee joint meeting the VAS scoring requirements
  5. K-L grading II-III，and the other knee joint grading is not higher than the target side
  6. Able to walk without assistance
  7. Willing to take contraceptive measures, female non pregnancy or lactation period

Exclusion Criteria:

  1. Concomitant bronchial asthma; Previous aspirin induced asthma (non steroidal anti-inflammatory drugs induced asthma)
  2. Active or high-risk bleeding diseases such as gastrointestinal ulcers may worsen due to the use of NSAIDs
  3. Have a history of myocardial infarction or undergo coronary artery bypass grafting surgery
  4. 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
  5. The combination of mental illnesses such as depression, dementia, and schizophrenia has been determined by researchers to affect the efficacy evaluation of study drugs
  6. Arthritis caused by other factors such as dermatomyositis, gouty arthritis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, purulent arthritis, systemic lupus erythematosus
  7. 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
  8. Severe osteoarthritis with obvious narrowing of joint space and indications for surgery
  9. Pain in other areas that affect the evaluation of bone and joint pain, such as hip joint pain or lower back pain
  10. Rashes and skin damage on the intended application of the study drug
  11. Abnormal liver and kidney function, anemia or thrombocytopenia
  12. 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
  13. 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
  14. 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
  15. During the research process, physical therapy and rehabilitation therapy for the lower limbs or waist are required
  16. Individuals with a history of allergies or contraindications to any component of this product or other losoprofen sodium preparations
  17. During this period, alcohol, drugs, and drug withdrawal may affect the effectiveness and safety evaluation of the study drug
  18. Participants in other clinical trials within 3 months
  19. Family members of the subjects in this study (cohabiting)
  20. Clinical research center employees directly involved in the operation, management, or support of this trial, or immediate family members
  21. Other situations that the researcher determines are not suitable for participating in this clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
placebo ，external use，once a day
Experimental: HRF2105 patch
Drug: HRF2105 patch
HRF2105 patch ，external use，once a day
Active Comparator: Loxoprofen patch
Drug: Loxoprofen patch
Loxoprofen patch ，external use，once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in VAS score from baseline at the end of treatment Day7 on rising from the chair
Time Frame: Day7
Day7

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in WOMAC pain score from baseline at the end of treatment (Day7)
Time Frame: Day7
Day7
Change in WOMAC stiffness score from baseline at the end of treatment (Day7)
Time Frame: Day7
Day7
Change in WOMAC daily activity score from baseline at the end of treatment (Day7)
Time Frame: Day7
Day7
Change in WOMAC total score from baseline at the end of treatment (Day7)
Time Frame: Day7
Day7
Daily average dose of remedial drug (Paracetamol) during the treatment period
Time Frame: Day0-Day7
Day0-Day7
Researcher satisfaction score
Time Frame: Day7
Day7
Subject satisfaction score
Time Frame: Day7
Day7
Skin irritation and sensitization scores
Time Frame: Day0-Day7
Day0-Day7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRF2105-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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