Clinical trial NCT03661996: An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA
Official title: An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX-4975-05 Intra-articular Injection in Subjects With Chronic, Moderate-to-Severe Osteoarthritis Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis
knee pain
non opioid
analgesic
capsaicin
pain
intra-articular
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 854
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: An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain.

Detailed description: This is an open-label, single injection (per knee), 8-week study to evaluate the comfort and ease of use of 5 different treatment regimens, and to evaluate the efficacy and safety of a single intra-articular (IA) injection, in one or both knees, of CNTX-4975-05 in subjects with chronic, moderate-to-severe knee OA pain. Procedural pain associated with IA injection of the investigational product, CNTX-4975-05, will be controlled primarily through adjunct controlled joint cooling and secondarily by pre-medication with IA lidocaine.

Eligibility criteria: Key Inclusion Criteria:

* Male or female subjects between 40 and 95 years of age (inclusive)
* Confirmation of osteoarthritis (OA) of the knee: radiography of both knees using standard standing films (scored by the investigator) or using the fixed flexion method, taken during the Screening Visit of CNTX-4975i-OA-301 or CNTX-4975i-OA-304.
* Confirmation of OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria
* For subjects for monoarticular knee injection, the index knee must have moderate to severe pain at screening associated with OA, which must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.

These subjects may have:

1. unilateral or bilateral OA, with the index knee having moderate to severe pain, and the contralateral knee having none to mild pain, OR
2. unilateral or bilateral OA, with the index knee having moderate to severe pain and the other knee having had a PJR or TJR within 5 years of the Screening Visit. The knee with the PJR/TJR is not to be injected with CNTX-4975-05.

For subjects for bilateral knee injection, the index knee must have moderate to severe pain at screening associated with OA, and greater pain in the index knee than in the contralateral knee. Their pain must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator. The index knee in these subjects is the one with the worst pain with walking. Where both knees have equal pain with walking, then the knee on the subject's dominant side will be designated the index knee.

For qualifying knee pain with walking, subjects will use an NPRS (0-10; 0=no pain, 10=worst possible pain) to rate their knee pain with walking (both knees, except knees with PJR/TJR). The PJR/TJR pain should be rated using the NPRS scale, but will not be a qualifying pain score.

* Body mass index ≤45 kg/m\^2.

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. Joint replacement of the contralateral knee is permitted for subjects who will not receive an injection in the contralateral (natural) knee.
* 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. Radicular or referred pain involving the index knee or from joint disease other than OA involving the index knee, such as, but not restricted to chondromalacia patellae, inflammatory disease, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, etc.
* Periarticular pain from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness, or subacute/acute pain from injury.
* Other chronic pain anywhere in the body that requires the use of chronic analgesic medications, including, but not limited to, local painful areas, myofascial pain syndromes, fibromyalgia, genetic, metabolic abnormalities, hematologic, or neuropathic pain.

Primary outcomes:
measure: Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction
timeFrame: Day 1 assessments
Secondary outcomes:
measure: Mean Change From Baseline in KOOS "Symptoms" Subscale Score by Subject Type
timeFrame: Baseline, Week 8
measure: Mean Change From Baseline in KOOS "Pain" Subscale Score by Subject Type
timeFrame: Baseline, Week 8
measure: Mean Change From Baseline in KOOS "Pain With Walking" Single Question Score by Subject Type
timeFrame: Baseline, Week 8
measure: Mean Change From Baseline in KOOS "Function (Daily Living)" Subscale Score by Subject Type
timeFrame: Baseline, Week 8
measure: Mean Change From Baseline in KOOS "Function (Sport and Recreational Activities)" Subscale Score by Subject Type
timeFrame: Baseline, Week 8
measure: Mean Change From Baseline in KOOS "Knee-Related Quality of Life" Subscale Score by Subject Type
timeFrame: Baseline, Week 8
measure: Mean Change From Baseline in Average Daily Pain With Walking NPRS (0-10) Score by Subject Type
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Orthopaedic Center-Research
state: Alabama
city: Peoria
country: United States
facility: Holland Center for Family Health
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Carmichael
country: United States
facility: Med Center Medical Clinic
state: California
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Maitland
country: United States
facility: Conquest Clinical Research
state: Florida
city: Miami
country: United States
facility: F&T Medical Research, Inc.
state: Florida
city: Miami
country: United States
facility: M&M Medical Center, Inc.
state: Florida
city: Mount Dora
country: United States
facility: Charter Research
state: Florida
city: Ocoee
country: United States
facility: Premier MED Family & Sports Medicine
state: Florida
city: Pinellas Park
country: United States
facility: Ascension Research
state: Florida
city: Sunrise
country: United States
facility: M&M Clinical Trials Sunrise
state: Florida
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: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Health
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Office of Robert P. Kaplan, DO
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Bellaire
country: United States
facility: First Surgical Hospital
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Hermann Drive Surgical Hospital
state: Texas
Study officials:
affiliation: Centrexion Therapeutics Corp
name: Randall M. Stevens, MD
role: STUDY_CHAIR
References: