Clinical trial NCT04683627: A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
Official title: A 12-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of HP-5000 Topical System (Patch) in Subjects With Osteoarthritis Pain of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis Pain of the Knee
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 370
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This is a multi-center, randomized, double-blind, and placebo-controlled phase 3 study evaluating the safety and efficacy of HP-5000 in subjects with OA pain of the knees. The study will consist of up to a 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics; a 12-week Double-blind Treatment Phase, and a 1-week safety Follow-up Phase.

Eligibility 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 criteria.
* Has an X-ray of the target knee, taken no more than 1 year before Baseline, showing evidence of OA.
* Has pain of OA in the designated/target study knee.

Exclusion Criteria:

* Body mass index (BMI) \> 40.
* Any subject who did not follow the restriction of prohibited therapies during Washout period.
* Arthritis of the target knee that is not caused by OA but caused by diseases such as rheumatoid arthritis, gout, psoriasis, syphilitic arthropathy, ochronosis, metabolic or other primary bone disease, or acute traumatic injury.

Primary outcomes:
measure: The change in Osteoarthritis of the Knee pain score between Baseline and Week 12. Primary efficacy endpoint
timeFrame: 12-week vs. baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Clearwater
country: United States
facility: Clinical Research of West Florida,Inc.
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research, LLC
state: Florida
city: Monroe
country: United States
facility: The Arthritis and Diabetes Clinic, Inc.
state: Louisiana
city: Jersey City
country: United States
facility: Noven Pharmaceuticals, Inc.
state: New Jersey
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
Study officials:
affiliation: Noven Pharmaceuticals, Inc.
name: Study Director
role: STUDY_DIRECTOR
References: