Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||40 Years - 85 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Noven Pharmaceuticals, Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|George Harb, MD, MPH|
|Principal Investigator Affiliation||Noven Pharmaceuticals, Inc.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Osteoarthritis Pain of the Knee|
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.
Experimental: HP-5000 Treatment
HP-5000 Topical Patch will be evaluated against placebo topical patches.
Placebo Comparator: Placebo Treatment
Placebo patches without diclofenac sodium will be used.
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
Drug: - Placebo patch
A placebo patch without diclofenac sodium will be used for the placebo arm.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.