A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
NCT ID: NCT04683627
Last Updated: 2025-09-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2020-12-29
2022-07-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis
NCT03277066
Irritation and Sensitization Study of HP-5000 Topical System
NCT04882319
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
NCT00504127
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
NCT00689273
A Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Knee Osteoarthritis Pain.
NCT05025787
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HP-5000 Treatment
HP-5000 Topical Patch will be evaluated against placebo topical patches.
Diclofenac sodium active topical patch
A topical patch with diclofenac sodium as active ingredient was used and evaluated for the treatment of OA pain of the knee.
Placebo Treatment
Placebo patches without diclofenac sodium will be used.
Placebo patch
A placebo patch without diclofenac sodium was used for the placebo arm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Diclofenac sodium active topical patch
A topical patch with diclofenac sodium as active ingredient was used and evaluated for the treatment of OA pain of the knee.
Placebo patch
A placebo patch without diclofenac sodium was used for the placebo arm.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* 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.
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Noven Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Noven Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Clinical Research of West Florida,Inc.
Clearwater, Florida, United States
Universal Axon Clinical Research, LLC
Doral, Florida, United States
The Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, United States
Noven Pharmaceuticals, Inc.
Jersey City, New Jersey, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Partners in Clinical Research
Cumberland, Rhode Island, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Quality Research Inc.
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HP-5000-US-07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.