ClinicalTrials.gg
Status unknownNCT06047483Updated Sep 21, 2023

A Trial of HRF2105 Patch in Relieving Pain of Osteoarthritis

A Phase 2 interventional study of HRF2105 patch and Loxoprofen patch in Analgesia and Anti-inflammatory of Osteoarthritis, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Analgesia and Anti-inflammatory of Osteoarthritis

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03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's planned enrollment of 90 is above the median of 75 across 1,089 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 570 studies on the registry; 85 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    HRF2105 patch

    Drug: HRF2105 patch

  • Active comparator
    Loxoprofen patch

    Drug: Loxoprofen patch

  • Placebo comparator
    placebo

    Drug: placebo

Interventions

  • DrugHRF2105 patch

    HRF2105 patch ,external use,once a day

  • Loxoprofen patch ,external use,once a day

  • Drugplacebo

    placebo ,external use,once a day

06

What researchers measure

Primary outcomes

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

    Time frame: Day7

Secondary outcomes

  1. Change in WOMAC pain score from baseline at the end of treatment (Day7)

    Time frame: Day7

  2. Change in WOMAC stiffness score from baseline at the end of treatment (Day7)

    Time frame: Day7

  3. Change in WOMAC daily activity score from baseline at the end of treatment (Day7)

    Time frame: Day7

  4. Change in WOMAC total score from baseline at the end of treatment (Day7)

    Time frame: Day7

  5. Daily average dose of remedial drug (Paracetamol) during the treatment period

    Time frame: Day0-Day7

  6. Researcher satisfaction score

    Time frame: Day7

  7. Subject satisfaction score

    Time frame: Day7

  8. Skin irritation and sensitization scores

    Time frame: Day0-Day7

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2023; primary completion for Dec 2023, 2 months later.

Of 32 phase 2 interventional studies under Agnosia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2023
First posted
Sep 21, 2023
StartEst.
Oct 2023
Primary completionEst.
Dec 2023
CompletionEst.
Dec 2023
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06047483
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Oct 2023 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Sep 21, 2023

Study contacts

Qin Liu
Contact
Qin.liu@hengrui.com
+0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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