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A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis

NCT03277066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2021-12-23

Study results available
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Summary

A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

Diclofenac Sodium Active Topical Patch 1

HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s)

DRUG

Diclofenac Sodium Active Topical Patch 2

HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s)

DRUG

Placebo patch

Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)

Sponsors & Collaborators

  • Noven Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Gunnar Klauss, MD, MSc · 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
2017-09-07
Primary Completion
2019-09-25
Completion
2019-09-25
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 NCT03277066 on ClinicalTrials.gov