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

NCT03277066 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HP-5000-US-05
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score

  To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 4. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.

  Baseline and 4 weeks

Secondary Outcomes (3)

• WOMAC Pain Score Week 2 Change From Baseline

  Baseline and 2 weeks

• WOMAC Stiffness Score Change From Baseline

  Baseline and 4 weeks

• WOMAC Physical Function Score

  Baseline and 4 weeks

Study Arms (2)

Diclofenac Sodium Active Topical Patch 1

EXPERIMENTAL

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

Drug: Diclofenac Sodium Active Topical Patch 1; Drug: Placebo patch

Diclofenac Sodium Active Topical Patch 2

EXPERIMENTAL

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

Drug: Diclofenac Sodium Active Topical Patch 2; Drug: Placebo patch

Interventions

Diclofenac Sodium Active Topical Patch 1 DRUG

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

Also known as: HP-5000

Diclofenac Sodium Active Topical Patch 1

Diclofenac Sodium Active Topical Patch 2 DRUG

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

Also known as: HP-5000

Diclofenac Sodium Active Topical Patch 2

Placebo patch DRUG

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

Also known as: Placebo treatment

Diclofenac Sodium Active Topical Patch 1; Diclofenac Sodium Active Topical Patch 2

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Noven Pharmaceuticals, Inc.: lead

Study Sites (1)

Noven Pharmaceuticals, Inc.

Jersey City, New Jersey, 07310, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Gunnar Klauss, MD
• Organization: Noven Pharmaceuticals, Inc.

gklauss@noven.com

1-551-233-2656

Study Officials

• Gunnar Klauss, MD, MSc

  Noven Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: September 7, 2017
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: December 23, 2021
• Results First Posted: December 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)