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

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ClinicalTrials.gov Identifier: NCT03277066
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Noven Pharmaceuticals, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: Diclofenac Sodium Active Topical Patch 1 Drug: Diclofenac Sodium Active Topical Patch 2 Drug: Placebo patch Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Diclofenac Sodium Active Topical Patch 1
Diclofenac sodium 1 topical patches will be compared against placebo patches.
Drug: Diclofenac Sodium Active Topical Patch 1
HP-5000 Active Topical Patch 1 will be evaluated against placebo topical patches.
Other Name: NSAID

Drug: Placebo patch
The study will evaluate active topical patches against topical placebo patches.
Other Name: Placebo treatment

Experimental: Diclofenac Sodium Active Topical Patch 2
Diclofenac sodium 2 topical patches will be compared against placebo patches.
Drug: Diclofenac Sodium Active Topical Patch 2
HP-5000 Active Topical Patch 2 will be evaluated against placebo topical patches.
Other Name: NSAID

Drug: Placebo patch
The study will evaluate active topical patches against topical placebo patches.
Other Name: Placebo treatment




Primary Outcome Measures :
  1. Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis pain score [ Time Frame: 4 weeks ]
    Primary efficacy endpoint is the change in Osteoarthritis of the Knee pain score between Baseline and Week 4.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277066


Contacts
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Contact: HP-5000 Project Team (551) 233-2652 HP5000@noven.com

Locations
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United States, New Jersey
Noven Pharmaceuticals, Inc. Recruiting
Jersey City, New Jersey, United States, 07310
Sponsors and Collaborators
Noven Pharmaceuticals, Inc.
Investigators
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Study Director: Yamina Merazga, PhD Noven Pharmaceuticals, Inc.

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Responsible Party: Noven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03277066     History of Changes
Other Study ID Numbers: HP-5000-US-05
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action