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Nonsteroidal Anti-inflammatory Drug (NSAID)

Diclofenac sodium active topical patch for Osteoarthritis

Phase 3
Waitlist Available
Research Sponsored by Noven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-week vs. baseline
Awards & highlights

Study Summary

This study is evaluating whether a new drug may help reduce pain for individuals with osteoarthritis.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-week vs. baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-week vs. baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change in Osteoarthritis of the Knee pain score between Baseline and Week 12. Primary efficacy endpoint

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HP-5000 TreatmentExperimental Treatment1 Intervention
HP-5000 Topical Patch will be evaluated against placebo topical patches.
Group II: Placebo TreatmentPlacebo Group1 Intervention
Placebo patches without diclofenac sodium will be used.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diclofenac sodium active topical patch
2020
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

Noven Pharmaceuticals, Inc.Lead Sponsor
8 Previous Clinical Trials
2,209 Total Patients Enrolled
1 Trials studying Osteoarthritis
289 Patients Enrolled for Osteoarthritis
Study DirectorStudy DirectorNoven Pharmaceuticals, Inc.
1,207 Previous Clinical Trials
489,310 Total Patients Enrolled
3 Trials studying Osteoarthritis
1,139 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
2020. "A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04683627.
~87 spots leftby Apr 2025
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