Analgesia and Anti-inflammatory of OsteoarthritisPhase 2NCT06047483
A Trial of HRF2105 Patch in Relieving Pain of Osteoarthritis
A Phase 2 study testing HRF2105 patch and Loxoprofen patch in people with Analgesia and Anti-inflammatory of Osteoarthritis, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The study is being conducted to evaluate the efficacy, and safety of HRF2105patch in relieving pain of Osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Analgesia and Anti-inflammatory of Osteoarthritis
- What is being tested?
- HRF2105 patch and Loxoprofen patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
The study is being conducted to evaluate the efficacy, and safety of HRF2105patch in relieving pain of Osteoarthritis.
- Being tested
- HRF2105 patch, Loxoprofen patch, placebo
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRF2105 patchDrug
HRF2105 patch ，external use，once a day
Loxoprofen patchDrug
Loxoprofen patch ，external use，once a day
placeboDrug
placebo ，external use，once a day
| Study group | Role | What they receive |
|---|---|---|
| HRF2105 patch | Experimental | Not described Receives: Drug: HRF2105 patch |
| Loxoprofen patch | Active comparator | Not described Receives: Drug: Loxoprofen patch |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS score from baseline at the end of treatment Day7 on rising from the chair
Measured: Day7
Secondary outcomes (8)
Change in WOMAC pain score from baseline at the end of treatment (Day7)
Measured: Day7
Change in WOMAC stiffness score from baseline at the end of treatment (Day7)
Measured: Day7
Change in WOMAC daily activity score from baseline at the end of treatment (Day7)
Measured: Day7
Change in WOMAC total score from baseline at the end of treatment (Day7)
Measured: Day7
Daily average dose of remedial drug (Paracetamol) during the treatment period
Measured: Day0-Day7
Researcher satisfaction score
Measured: Day7
Subject satisfaction score
Measured: Day7
Skin irritation and sensitization scores
Measured: Day0-Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia and Anti-inflammatory of OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047483
- Sponsor's protocol ID
- HRF2105-201
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06047483
- Acronym / sponsor ID
- HRF2105-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy, and safety of HRF2105patch in relieving pain of Osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HRF2105 patch | Experimental | Drug: HRF2105 patch |
| Loxoprofen patch | Active comparator | Drug: Loxoprofen patch |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRF2105 patchHRF2105 patch ，external use，once a day | Drug | HRF2105 patch |
| Loxoprofen patchLoxoprofen patch ，external use，once a day | Drug | Loxoprofen patch |
| placeboplacebo ，external use，once a day | Drug | placebo |
Primary outcome
Change in VAS score from baseline at the end of treatment Day7 on rising from the chair
Time frame: Day7
8 secondary outcomes
Change in WOMAC pain score from baseline at the end of treatment (Day7)
Time frame: Day7
Change in WOMAC stiffness score from baseline at the end of treatment (Day7)
Time frame: Day7
Change in WOMAC daily activity score from baseline at the end of treatment (Day7)
Time frame: Day7
Change in WOMAC total score from baseline at the end of treatment (Day7)
Time frame: Day7
Daily average dose of remedial drug (Paracetamol) during the treatment period
Time frame: Day0-Day7
Researcher satisfaction score
Time frame: Day7
Subject satisfaction score
Time frame: Day7
Skin irritation and sensitization scores
Time frame: Day0-Day7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRF2105 patch and Loxoprofen patch in people with Analgesia and Anti-inflammatory of Osteoarthritis, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Liu (+0518-82342973, Qin.liu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS score from baseline at the end of treatment Day7 on rising from the chair (time frame: Day7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.