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A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03660943
Recruitment Status : Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Placebo Drug: CNTX-4975-05 (trans-capsaicin) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 9, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Capsaicin

Arm Intervention/treatment
Placebo Comparator: Placebo
Intra-articular Placebo Injection
Drug: Placebo
Receiving Placebo Injection

Experimental: CNTX-4975-05 (trans-capsaicin)
Intra-articular 1.0 mg CNTX-4975-05 Injection
Drug: CNTX-4975-05 (trans-capsaicin)
Receiving CNTX-4975-05 Injection




Primary Outcome Measures :
  1. Analgesic Efficacy using Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline at Week 12 ]
    Evaluation of the analgesic efficacy on pain with walking of CNTX-4975-05, compared to placebo, when administered as the first intra-articular (IA) injection into the index knee using NPRS (0-10; 0 = no pain, 10 = worst pain ever).


Secondary Outcome Measures :
  1. Analgesic Efficacy using Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline through 52 weeks ]
    Evaluation of the analgesic efficacy of CNTX-4975-05 using NPRS (0-10; 0 = no pain, 10 = worst pain ever).

  2. Stiffness and Function using WOMAC [ Time Frame: Baseline through 52 weeks ]
    Evaluation of pain, stiffness and function as assessed by WOMAC A, B, and C (11-box Numerical Rating Scale).

  3. Global Improvement in Osteoarthritis (OA) Pain using Patient Global Impression of Change (PGIC) [ Time Frame: Baseline through 52 weeks ]
    Evaluation of OA pain as assessed by PGIC (1-7; 1 = very much improved, 7 = very much worse).

  4. Quality of Life and Effect on Sleep using EQ-5D-5L Questionnaire [ Time Frame: Baseline through 52 weeks ]
    Evaluation of the quality of life as assessed by EQ-5D-5L Questionnaire consisting of daily functioning (1-5; 1 = no/none, 5 = extremely) and daily health (0-100; 0 = worst, 100 = best).

  5. Duration of Analgesic Efficacy using NPRS [ Time Frame: Baseline through 52 weeks ]
    Evaluation of the duration of analgesic efficacy of CNTX-4975-05 as measured by the time from Day 1 (Baseline) to the return of Baseline (NPRS pain with walking) pain.

  6. Percentage of Responders [ Time Frame: Baseline through 52 weeks ]
    Evaluation of the percentage of responders.

  7. Second Dose: Analgesic Efficacy using Numeric Pain Rating Scale (NPRS) [ Time Frame: Week 38 and through Week 52 ]
    Evaluation of the analgesic efficacy of CNTX-4975-05 using NPRS (0-10; 0 = no pain, 10 = worst pain ever).

  8. Second Dose: Percentage of Responders [ Time Frame: Week 38 and through Week 52 ]
    Evaluation of the percentage of responders.

  9. Second Dose: Pain, Stiffness and Function using WOMAC [ Time Frame: Week 38 and through Week 52 ]
    Evaluation of stiffness and function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A, B, and C subscales (11-box Numerical Rating Scale 0-11; 0 = no pain/stiffness/difficulty, 10= extreme).

  10. Second Dose: Global Improvement in Osteoarthritis (OA) Pain using Patient Global Impression of Change (PGIC) [ Time Frame: Week 38 and through Week 52 ]
    Evaluation of osteoarthritis pain and overall improvement as assessed by Patient Global Impression of Change (PGIC) (1-7; 1 = very much improved, 7 = very much worse).

  11. Quality of Life and Effect on Sleep using EQ-5D-5L Questionnaire [ Time Frame: Week 38 and through Week 52 ]
    Evaluation of the quality of life as assessed by EQ-5D-5L Questionnaire consisting of daily functioning (1-5; 1 = no/none, 5 = extremely) and daily health (0-100; 0 = worst, 100 = best).



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660943


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Locations
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United States, Arizona
Holland Center for Family Health
Glendale, Arizona, United States, 85306
GB Family Care
Phoenix, Arizona, United States, 85037
Arizona Research Center
Phoenix, Arizona, United States, 85053
United States, California
Med Center Medical Clinic
Carmichael, California, United States, 95608
TriWest Research Associates
El Cajon, California, United States, 92020
Arthritis Care and Research Center, Inc. (ACRC Studies)
Poway, California, United States, 92064
United States, Connecticut
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States, 33014
Panamerican Health Center, Inc.
Miami, Florida, United States, 33126
Well Pharma Medical Research, Corp
Miami, Florida, United States, 33143
Quality Research & Medical Center LLC
Miami, Florida, United States, 33186
Journey Research, Inc.
Oldsmar, Florida, United States, 34677
M&M Clinical Trials Sunrise
Sunrise, Florida, United States, 33351
Conquest Research
Winter Park, Florida, United States, 32789
United States, Georgia
Better Health Clinical Research, Inc.
Newnan, Georgia, United States, 30265
United States, Illinois
Healthcare Research Network, LLC
Flossmoor, Illinois, United States, 60422
Affinity Clinical Research Institute
Oak Brook, Illinois, United States, 60523
United States, Louisiana
DelRicht Research
New Orleans, Louisiana, United States, 70115
United States, Maryland
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, Massachusetts
BTC of New Bedford, LLC
New Bedford, Massachusetts, United States, 02740
United States, Missouri
Healthcare Research Network
Hazelwood, Missouri, United States, 63042
United States, Nevada
Office of Robert P. Kaplan, DO
Las Vegas, Nevada, United States, 89119
United States, New York
Drug Trials America
Hartsdale, New York, United States, 10530
United States, North Dakota
Lillestol Research LLC
Fargo, North Dakota, United States, 58104
United States, South Carolina
Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Heartland Medical, PC
New Tazewell, Tennessee, United States, 37825
United States, Texas
Hermann Drive Surgical Hospital
Houston, Texas, United States, 77004
Clinical Trials of Texas, Inc
San Antonio, Texas, United States, 78229
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States, 78258
United States, Virginia
Spectrum Medical, Inc.
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Centrexion Therapeutics
Investigators
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Study Chair: Randall Stevens, MD Centrexion Therapeutics

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Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT03660943     History of Changes
Other Study ID Numbers: CNTX-4975i-OA-304
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Centrexion Therapeutics:
Osteoarthritis
Knee Pain

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs