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

NCT ID: NCT03277066

Last Updated: 2021-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2019-09-25

Brief Summary

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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

Detailed Description

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This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist of up to 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week safety Follow-up Period.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Diclofenac Sodium Active Topical Patch 1

Diclofenac sodium 1 topical patches will be compared against placebo patches.

Group Type EXPERIMENTAL

Diclofenac Sodium Active Topical Patch 1

Intervention Type DRUG

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

Placebo patch

Intervention Type DRUG

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

Diclofenac Sodium Active Topical Patch 2

Diclofenac sodium 2 topical patches will be compared against placebo patches.

Group Type EXPERIMENTAL

Diclofenac Sodium Active Topical Patch 2

Intervention Type DRUG

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

Placebo patch

Intervention Type DRUG

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

Interventions

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Diclofenac Sodium Active Topical Patch 1

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

Intervention Type DRUG

Diclofenac Sodium Active Topical Patch 2

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

Intervention Type DRUG

Placebo patch

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

Intervention Type DRUG

Other Intervention Names

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HP-5000 HP-5000 Placebo treatment

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee according to the American College of Rheumatology (ACR) criteria, including:
* Symptoms for at least 6 months prior to screening, AND
* Knee pain in the target knee for 30 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND
* The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over the counter (OTC) per recommendation of a physician or prescribed.

Exclusion Criteria

* Body mass index (BMI) \> 40
* Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue medication) during Screening Washout Period.
* Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Noven Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunnar Klauss, MD, MSc

Role: STUDY_DIRECTOR

Noven Pharmaceuticals, Inc.

Locations

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Noven Pharmaceuticals, Inc.

Jersey City, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HP-5000-US-05

Identifier Type: -

Identifier Source: org_study_id