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A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee

NCT04683627 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2025-09-04

Study results available
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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

Conditions

  • Osteoarthritis Pain of the Knee

Interventions

DRUG

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.

DRUG

Placebo patch

A placebo patch without diclofenac sodium was used for the placebo arm.

Sponsors & Collaborators

  • Noven Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Noven Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2022-07-18
Completion
2022-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04683627 on ClinicalTrials.gov