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NCT04683627 · ClinicalTrials.gov registry record · Phase 3
A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
A Phase 3 study of Osteoarthritis Pain of the Knee, sponsored by Noven Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 370
- Enrollment target
- 10
- Study locations
NCT04683627: Completed Phase 3 study of Osteoarthritis Pain of the Knee, sponsored by Noven Pharmaceuticals.
NCT04683627 is a Phase 3 study of Osteoarthritis Pain of the Knee that has completed, run by Noven Pharmaceuticals. The registered enrollment target is 370 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04683627, a Phase 3 study of Osteoarthritis Pain of the Knee, has completed, sponsored by Noven Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 370 participants
- Enrollment target
- 10
- Study locations
Study 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
Primary Outcome
To evaluate efficacy of HP-5000 patch treatment compared with HP-5000 placebo patch treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 12. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score
Conditions Studied
Interventions
- DRUG Placebo patch
- DRUG Diclofenac sodium active topical patch
Study Locations (10)
Florida
- Clinical Research of West Florida,Inc. - Clearwater
- Universal Axon Clinical Research, LLC - Doral
Texas
- Metroplex Clinical Research Center - Dallas
- Quality Research Inc. - San Antonio
Arkansas
- Applied Research Center of Arkansas - Little Rock
Louisiana
- The Arthritis and Diabetes Clinic, Inc. - Monroe
New Jersey
- Noven Pharmaceuticals, Inc. - Jersey City
Ohio
- Velocity Clinical Research - Cincinnati
Rhode Island
- Partners in Clinical Research - Cumberland
South Carolina
- Palmetto Clinical Research - Summerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2020-12-29 |
| Est. Completion | 2022-07-25 |
| Phase | Phase 3 |
What the finished NCT04683627 record still lists
NCT04683627 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Osteoarthritis Pain of the Knee appearing as the primary indexed condition, and to 2 interventions - of which Placebo patch is the first listed.
NCT04683627 lists 10 locations in 8 states (Florida, Texas, Arkansas).
Frequently Asked Questions
What is clinical trial NCT04683627 about?
NCT04683627 is a clinical study titled "A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 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
What is the current status of trial NCT04683627?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 370 participants. The study started on 2020-12-29. Estimated completion is 2022-07-25.
What conditions does trial NCT04683627 study?
This clinical trial studies the following conditions: Osteoarthritis Pain of the Knee.
What interventions are being tested in trial NCT04683627?
The interventions under investigation include: Placebo patch (DRUG), Diclofenac sodium active topical patch (DRUG).
Who is sponsoring clinical trial NCT04683627?
This trial is sponsored by Noven Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04683627 being conducted?
This trial has 10 study locations across Arkansas, Florida, Louisiana, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04683627's enrollment target sits among peer trials
370 993rd of 2000 higher than 1,006 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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