Clinical trial NCT03429049: A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
Official title: A Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: analgesic
non-opioid
capsaicin
intra-articular
osteoarthritis
pain
knee pain
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-02-12
Enrollment: 332
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.


Eligibility criteria: Key Inclusion Criteria:

* Male or female subjects between 40 and 95 years of age (inclusive) at the time of the Screening Visit with the ability to comply with answering the electronic diary using the study-provided tablet computers.
* Confirmation of osteoarthritis (OA) of the knee.
* Confirmation of OA of the index knee.
* Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
* BMI ≤45 kg/m\^2.
* Must have failed 2 or more prior therapies.
* Females not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile, or practicing one of the following medically acceptable methods of birth control throughout the study period.
* Subject agrees to stay on their current pain medication (including over the counter (OTC) medications) from the time of Screening through Week 12. The current pain medication must be taken only for pain in the index knee, and not for another pain indication.
* Subject agrees to take only the allowed rescue medications for OA knee pain of the index knee from the time of Screening through study completion and agrees to use no topical medications for OA knee pain during the trial.

Key Exclusion Criteria:

* Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months.
* Prior arthroscopic surgery of the index knee within 6 months of Screening.
* Any painful conditions of the index knee due to joint disease other than OA.
* Periarticular pain from any cause.
* Pain in the non-index knee that is \>3 on a numeric pain rating scale (NPRS) (0-10) when walking or at rest.
* Other chronic pain anywhere in the body that requires the use of analgesic medications.
* Instability of the index knee.
* Misalignment (\>10 degrees varus or valgus) of the index knee on standing.
* Documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging.
* Physical/ occupational/ chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or need for such therapy during the study.
* Plans to have surgery, other invasive procedures, or IA injections while participating in the study.
* Has used topical capsaicin on the index knee within 90 days of Screening.
* Current use of opioids for any condition other than for OA of the index knee.
* Corticosteroid injection into the index knee within 90 days of Screening.
* Received IA viscosupplementation (eg, Synvisc®, Hyalgan®) within 90 days of Screening.

Primary outcomes:
measure: Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Orthopaedic Center - Research
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Research, Inc
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc
state: Alabama
city: Tucson
country: United States
facility: Noble Clinical Research, LLC
state: Arizona
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: La Mesa
country: United States
facility: Biosolutions Clinical Research Center
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: M&M Medical Center, Inc
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Orlando
country: United States
facility: Jewett Orthopaedic
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Stockbridge
country: United States
facility: Atlanta Orthopaedic Institute, LLC
state: Georgia
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Overland Park
country: United States
facility: Mid America PolyClinic
state: Kansas
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: North Attleboro
country: United States
facility: Tristan Medical Enterprises PC, dba
state: Massachusetts
city: Traverse City
country: United States
facility: Medical Research Associates, Inc
state: Michigan
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Toledo
country: United States
facility: Bone Joint & Spine Surgeons, Inc
state: Ohio
city: Austin
country: United States
facility: Tekton Research, Inc
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Plano
country: United States
facility: Clinical Investigations of Texas
state: Texas
city: Arlington
country: United States
facility: Ortho Virginia
state: Virginia
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
Study officials:
affiliation: Centrexion Therapeutics
name: Randall M. Stevens, MD
role: STUDY_CHAIR
References: