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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

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ClinicalTrials.gov Identifier: NCT03660943
Recruitment Status : Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

Tracking Information
First Submitted Date  ICMJE August 27, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date August 5, 2019
Actual Study Start Date  ICMJE September 9, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03660943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • Percentage of Responders [ Time Frame: Baseline through 52 weeks ]
    Evaluation of the percentage of responders.
  • 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).
  • Second Dose: Percentage of Responders [ Time Frame: Week 38 and through Week 52 ]
    Evaluation of the percentage of responders.
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • Percentage of Responders [ Time Frame: Baseline through 52 weeks ]
    Evaluation of the percentage of responders.
  • 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).
  • Second Dose: Percentage of Responders [ Time Frame: Week 38 and through Week 52 ]
    Evaluation of the percentage of responders.
  • Second Dose: Pain, Stiffness and Function using WOMAC [ Time Frame: Week 38 and through Week 52 ]
    Evaluation of stiffness and function as assessed by WOMAC A, B, and C (11-box Numerical Rating Scale).
  • Second Dose: Global Improvement is Osteoarthritis (OA) Pain using Patient Global Impression of Change (PGIC) [ Time Frame: Week 38 and through Week 52 ]
    Evaluation of OA pain as assessed by PGIC (1-7; 1 = very much improved, 7 = very much worse).
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: Placebo
    Receiving Placebo Injection
  • Drug: CNTX-4975-05 (trans-capsaicin)
    Receiving CNTX-4975-05 Injection
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intra-articular Placebo Injection
    Intervention: Drug: Placebo
  • Experimental: CNTX-4975-05 (trans-capsaicin)
    Intra-articular 1.0 mg CNTX-4975-05 Injection
    Intervention: Drug: CNTX-4975-05 (trans-capsaicin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 7, 2019)
332
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2018)
325
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03660943
Other Study ID Numbers  ICMJE CNTX-4975i-OA-304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centrexion Therapeutics
Study Sponsor  ICMJE Centrexion Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Randall Stevens, MD Centrexion Therapeutics
PRS Account Centrexion Therapeutics
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP