A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
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ClinicalTrials.gov Identifier: NCT04683627 |
Recruitment Status :
Recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis Pain of the Knee | Drug: Diclofenac sodium active topical patch Drug: Placebo patch | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 352 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A 12-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of HP-5000 Topical System (Patch) in Subjects With Osteoarthritis Pain of the Knee |
Estimated Study Start Date : | December 2020 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Experimental: HP-5000 Treatment
HP-5000 Topical Patch will be evaluated against placebo topical patches.
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Drug: Diclofenac sodium active topical patch
A topical patch with diclofenac sodium will be evaluated against the placebo patch for the treatment of OA pain of the knee
Other Name: HP-5000 |
Placebo Comparator: Placebo Treatment
Placebo patches without diclofenac sodium will be used.
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Drug: Placebo patch
A placebo patch without diclofenac sodium will be used for the placebo arm.
Other Name: Placebo |
- The change in Osteoarthritis of the Knee pain score between Baseline and Week 12. Primary efficacy endpoint [ Time Frame: 12-week vs. baseline ]Evaluate efficacy and safety of HP-5000 topical patches in subjects with OA of the knee by measuring change in Osteoarthritic pain score

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Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee according to the American College of Rheumatology criteria.
- Has an X-ray of the target knee, taken no more than 1 year before Baseline, showing evidence of OA.
- Has pain of OA in the designated/target study knee.
Exclusion Criteria:
- Body mass index (BMI) > 40.
- Any subject who did not follow the restriction of prohibited therapies during Washout period.
- Arthritis of the target knee that is not caused by OA but caused by diseases such as rheumatoid arthritis, gout, psoriasis, syphilitic arthropathy, ochronosis, metabolic or other primary bone disease, or acute traumatic injury.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683627
Contact: HP-5000 Project Team | (551) 233-2656 | HP5000@noven.com | |
Contact: George Harb, MD, MPH |
United States, New Jersey | |
Noven Pharmaceuticals, Inc. | Recruiting |
Jersey City, New Jersey, United States, 07310 | |
Contact: George Harb, MD, MPH |
Study Director: | George Harb, MD, MPH | Noven Pharmaceuticals, Inc. |
Responsible Party: | Noven Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT04683627 |
Other Study ID Numbers: |
HP-5000-US-07 |
First Posted: | December 24, 2020 Key Record Dates |
Last Update Posted: | December 24, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |