Clinical trial NCT02558439: Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging 24-Week Study to Evaluate the Safety and Efficacy of a Single Injection of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 175
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of a single injection of CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain.


Eligibility criteria: Inclusion Criteria:

* Radiography of both knees with a posterior-anterior, fixed flexion view taken during the Screening period. The index knee must show evidence of chronic OA.
* Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 2 months prior to Screening, as assessed by the Investigator.
* A specified mean pain score in the index knee over the 7 days prior to dosing, based on question A1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC A1).
* Specified baseline and screening scores on the WOMAC A1
* Body Mass Index ≤ 45 kg/m2.
* Subjects must have had a therapeutic failure (no relief, or inadequate relief), and/or AEs resulting in stopping treatment, and/or contraindication to the standard of care appropriate to the severity of the index knee OA pain they are experiencing.

Exclusion Criteria:

* Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 12 months.
* Prior arthroscopic surgery of the index knee within 3 months of Screening.
* Any painful conditions of the index knee due to joint disease other than OA.
* Mild pain in the non-index knee when walking.
* Other chronic pain anywhere in the body that requires the use of analgesic medications.
* Secondary OA of the index knee due to acute traumatic injury.
* Significant current or past instability (e.g., cruciate ligament tear or rupture or previous repair) or misalignment (\> 10 degrees varus or valgus) of the index knee
* Has used topical capsaicin on the index knee within 90 days of Screening.
* Corticosteroid injection in the index knee within 90 days of Screening.
* Received IA viscosupplementation (e.g., Synvisc®, Hyalgan®) within 90 days of Screening.
* Prior participation in an ALGRX 4975 or CNTX-4975 study.
* Has any of the following characteristics:

  1. active or historic substance use disorder within the previous year as defined by the Diagnostic and Statistical Manual for Mental Health Disorders, fifth edition, or
  2. tests positive upon urine drug screen for a substance of abuse.
* Has moderate to severe depression or anxiety.

Primary outcomes:
measure: Change from Baseline through Week 12 in average knee index pain with walking over previous 24 hours using WOMAC A1 question in subjects treated with CNTX-4975 1.0 mg compared to placebo in subjects with osteoarthritis (OA) of the knee
timeFrame: At 12 Weeks
Secondary outcomes:
measure: Change from Baseline through Week 12 in average index knee pain with walking using WOMAC A1 question in subjects treated with CNTX 0.5 mg compared to placebo
timeFrame: At 12 Weeks
measure: Change from Baseline to each study visit through Week 24 in average index knee pain with walking using WOMAC A1 in subjects treated with CNTX-4975 compared to placebo
timeFrame: Up to 24 weeks
measure: Change from Baseline through Week 4 in the average index knee pain with walking using the WOMAC A1 question
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Tucson
country: United States
facility: Advanced Arizona Clinical Research
state: Arizona
city: Anaheim
country: United States
facility: Dream Team Clinical Research, LLC
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, LLC
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates
state: California
city: La Mesa
country: United States
facility: BioSolutions Clinical Research Center
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Finlay Research Clinic
state: Florida
city: Hialeah
country: United States
facility: Eastern Research
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Miami
country: United States
facility: M&M Medical Center, Inc
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: The Villages
country: United States
facility: Compass Research, LLC
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
Study officials:
References:
citation: Stevens RM, Ervin J, Nezzer J, Nieves Y, Guedes K, Burges R, Hanson PD, Campbell JN. Randomized, Double-Blind, Placebo-Controlled Trial of Intraarticular Trans-Capsaicin for Pain Associated With Osteoarthritis of the Knee. Arthritis Rheumatol. 2019 Sep;71(9):1524-1533. doi: 10.1002/art.40894. Epub 2019 Jul 17.