- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683627
A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
July 17, 2023 updated by: Noven Pharmaceuticals, Inc.
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
370
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arkansas
-
Little Rock, Arkansas, United States, 72212
- Applied Research Center of Arkansas
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Florida
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Clearwater, Florida, United States, 33765
- Clinical Research of West Florida,Inc.
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Doral, Florida, United States, 33166
- Universal Axon Clinical Research, LLC
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Louisiana
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Monroe, Louisiana, United States, 71203
- The Arthritis and Diabetes Clinic, Inc.
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New Jersey
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Jersey City, New Jersey, United States, 07310
- Noven Pharmaceuticals, Inc.
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Ohio
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Cincinnati, Ohio, United States, 45242
- Velocity Clinical Research
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Rhode Island
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Cumberland, Rhode Island, United States, 02864
- Partners in Clinical Research
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South Carolina
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Summerville, South Carolina, United States, 29485
- Palmetto Clinical Research
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Texas
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Dallas, Texas, United States, 75231
- Metroplex Clinical Research Center
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San Antonio, Texas, United States, 78209
- Quality Research Inc.
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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
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HP-5000 Treatment
HP-5000 Topical Patch will be evaluated against placebo topical patches.
|
A topical patch with diclofenac sodium as active ingredient was used and evaluated for the treatment of OA pain of the knee.
Other Names:
|
Placebo Comparator: Placebo Treatment
Placebo patches without diclofenac sodium will be used.
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A placebo patch without diclofenac sodium was used for the placebo arm.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in Osteoarthritis of the Knee pain score between Baseline and Week 12. Primary efficacy endpoint
Time Frame: 12-week vs. baseline
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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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12-week vs. baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, Noven Pharmaceuticals, Inc.
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 (Actual)
December 29, 2020
Primary Completion (Actual)
July 18, 2022
Study Completion (Actual)
July 25, 2022
Study Registration Dates
First Submitted
December 21, 2020
First Submitted That Met QC Criteria
December 21, 2020
First Posted (Actual)
December 24, 2020
Study Record Updates
Last Update Posted (Actual)
July 20, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
Other Study ID Numbers
- HP-5000-US-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
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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