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A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04683627
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics ( Noven Pharmaceuticals, Inc. )

Study Description
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Brief Summary:
A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) Pain of the Knee

Condition or disease Intervention/treatment Phase
Osteoarthritis Pain of the Knee Drug: Diclofenac sodium active topical patch Drug: Placebo patch Phase 3

Detailed Description:
This is a multi-center, randomized, double-blind, and placebo-controlled phase 3 study evaluating the safety and efficacy of HP-5000 in subjects with OA pain of the knees. The study will consist of up to a 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics; a 12-week Double-blind Treatment Phase, and a 1-week safety Follow-up Phase.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: HP-5000 Treatment
HP-5000 Topical Patch will be evaluated against placebo topical patches.
 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.
 Drug: Placebo patch
A placebo patch without diclofenac sodium will be used for the placebo arm.
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: HP-5000 Project Team (551) 233-2656 HP5000@noven.com
Contact: George Harb, MD, MPH

Locations
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United States, New Jersey
Noven Pharmaceuticals, Inc. Recruiting
Jersey City, New Jersey, United States, 07310
Contact: George Harb, MD, MPH         
Sponsors and Collaborators
Noven Pharmaceuticals, Inc.
Investigators
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Study Director: George Harb, MD, MPH Noven Pharmaceuticals, Inc.
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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