Clinical trial NCT03660943: A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
Official title: A Randomized, Double-blind, Placebo-controlled, 2-Injection, 52-Week Study to Evaluate the Efficacy and Safety of Intra-articular Injections 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: Osteoarthritis
Knee Pain
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-09-07
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 randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis 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 the 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.
* Body Mass Index (BMI) ≤45 kg/m\^2
* Must have failed 2 or more prior therapies.

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 the OA.
* Periarticular pain from any cause.
* 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: Mean Change From Baseline in WOMAC A (Pain) Dimension
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
timeFrame: Baseline, Week 12
measure: Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension
timeFrame: Baseline, Week 12
measure: Mean Change From Study Baseline in WOMAC C (Function) Dimension
timeFrame: Baseline, Week12
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Holland Center for Family Health
state: Arizona
city: Phoenix
country: United States
facility: GB Family Care
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Carmichael
country: United States
facility: Med Center Medical Clinic
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates
state: California
city: Poway
country: United States
facility: Arthritis Care and Research Center, Inc. (ACRC Studies)
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Panamerican Health Center, Inc.
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp
state: Florida
city: Miami
country: United States
facility: Quality Research & Medical Center LLC
state: Florida
city: Oldsmar
country: United States
facility: Journey Research, Inc.
state: Florida
city: Sunrise
country: United States
facility: M&M Clinical Trials Sunrise
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc.
state: Georgia
city: Flossmoor
country: United States
facility: Healthcare Research Network, LLC
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Clinical Research Institute
state: Illinois
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: New Bedford
country: United States
facility: BTC of New Bedford, LLC
state: Massachusetts
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Las Vegas
country: United States
facility: Office of Robert P. Kaplan, DO
state: Nevada
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: North Charleston
country: United States
facility: Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine
state: South Carolina
city: New Tazewell
country: United States
facility: Heartland Medical, PC
state: Tennessee
city: Bellaire
country: United States
facility: First Surgical Hospital
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc
state: Texas
city: San Antonio
country: United States
facility: DCT-Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
Study officials:
affiliation: Centrexion Therapeutics
name: Randall Stevens, MD
role: STUDY_CHAIR
References: