A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429049
• Other study ID #: CNTX-4975i-OA-301
• Status: Completed
• Phase: Phase 3
• Start date: January 24, 2018
• Est. completion date: November 22, 2019

Study information

• Verified date: July 2022
• Source: Centrexion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• CNTX-4975-05
Receiving CNTX-4975-05 injection
• Placebo
Receiving Placebo injection

Locations

Country	Name	City	State
United States	Orange County Research Institute	Anaheim	California
United States	Ortho Virginia	Arlington	Virginia
United States	Tekton Research, Inc	Austin	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	Alabama Orthopaedic Center - Research	Birmingham	Alabama
United States	Cahaba Research, Inc	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Core Healthcare Group	Cerritos	California
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Tampa Bay Medical Research, Inc	Clearwater	Florida
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Biosolutions Clinical Research Center	La Mesa	California
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	Drug Studies America	Marietta	Georgia
United States	Georgia Institute for Clinical Research, LLC	Marietta	Georgia
United States	M&M Medical Center, Inc	Miami	Florida
United States	Coastal Clinical Research, Inc	Mobile	Alabama
United States	Tristan Medical Enterprises PC, dba	North Attleboro	Massachusetts
United States	Providence Clinical Research	North Hollywood	California
United States	Sensible Healthcare, LLC	Ocoee	Florida
United States	Jewett Orthopaedic	Orlando	Florida
United States	Mid America PolyClinic	Overland Park	Kansas
United States	Clinical Investigations of Texas	Plano	Texas
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Medical Associates Research Group	San Diego	California
United States	Encompass Clinical Research	Spring Valley	California
United States	Atlanta Orthopaedic Institute, LLC	Stockbridge	Georgia
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Bone Joint & Spine Surgeons, Inc	Toledo	Ohio
United States	Medical Research Associates, Inc	Traverse City	Michigan
United States	Noble Clinical Research, LLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Centrexion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee	Average daily OA pain in the index knee while walking was evaluated using a 0 to 10 Numerical Pain Rating Scale (NPRS) (0 = no pain and 10 = worst possible pain). 0 was the best score and 10 was the worst score.; Subjects used an ePRO at bedtime (9:00 PM ± 3 hours) to record on a daily basis their average daily OA knee pain score with walking during the previous 24 hours.	Baseline, Week 12
Secondary	Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score	The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).; The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome.; The pain dimension includes 5 items about the amount of pain experienced doing various activities (walking, stair climbing, nocturnal, at rest, weight bearing). The score ranges from 0 to 50.	Baseline, Week 12
Secondary	Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score	The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).; The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome.; The stiffness dimension has 2 items: joint stiffness upon wakening and joint stiffness later in the day. The score ranges from 0 to 20.	Baseline, Week 12
Secondary	Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score	The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).; The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome.; The function dimension asks about the degree of difficulty in doing 17 activities due to the reference joint. The score ranges from 0 to 170.	Baseline, Week 12