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

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ClinicalTrials.gov Identifier: NCT03429049
Recruitment Status : Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

Brief Summary:
This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the efficacy and safety of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis knee pain.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : February 29, 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
Single intra-articular 1.0 mg Placebo Injection
Drug: Placebo
Receiving Placebo injection

Experimental: CNTX-4975-05
Single intra-articular 1.0 mg CNTX-4975-05 (trans-capsaicin) injection
Drug: CNTX-4975-05 (trans-capsaicin)
Receiving CNTX-4975-05 injection




Primary Outcome Measures :
  1. Index Knee Pain [ Time Frame: Baseline at Week 12 ]
    Change in the average pain in the index knee with walking over the previous 24 hours using the numeric pain rating scale (NPRS) (0-10).


Secondary Outcome Measures :
  1. Area Under the Curve (AUC) Change in Average Pain in the Index Knee [ Time Frame: Baseline through Week 12 ]
    AUC calculated on change in the average pain with walking in the index knee over the previous 24 hours, using the NPRS (0-10).

  2. Change in the Average Function in the Index Knee [ Time Frame: Baseline through Week 12 ]
    Change in the average function in the index knee, using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) C function subscale.

  3. AUC Change in the Average Pain in the Index Knee [ Time Frame: Baseline through Week 26 ]
    AUC calculated in the average pain in the index knee with walking over the previous 24 hours, using the NPRS (0-10), in subject.

  4. Change in the Average Pain in the Index Knee with Walking [ Time Frame: Baseline through Week 26 ]
    Change in the average pain in the index knee with walking over the past 24 hours, using the NPRS (0-10).

  5. Change in the Average Pain in the Index Knee [ Time Frame: Baseline through Week 52 ]
    Change in the average pain in the index knee, using the WOMAC A pain subscale.

  6. Change in the Average Stiffness in the Index Knee [ Time Frame: Baseline through Week 52 ]
    Change in the average stiffness in the index knee, using the WOMAC B stiffness subscale.

  7. Patient Global Impression of Change (PGIC) for Index Knee Pain [ Time Frame: At Each Study Visit through Week 52 ]
    Rating of the index knee pain compared to Baseline using the PGIC scale (1-7) where 1 = very much improved and 7 = very much worse.

  8. Change in Quality of Life (QOL) - SF-36 Health Survey [ Time Frame: Baseline through Week 52 ]
    Change in the QOL as measured by the SF-36 Health Survey.

  9. Change in QOL - EQ-5D-5L [ Time Frame: Baseline through Week 52 ]
    Change in QOL as measured by the EQ-5D-5L.

  10. Change in the Average Pain in the Index Knee [ Time Frame: Baseline through Weeks 38 and 52 ]
    Change in the average pain in the index knee with walking over the previous 24 hours, using the NPRS (0-10).

  11. Change in the Average Function in the Index Knee [ Time Frame: Baseline through Week 52 ]
    Change in the average function in the index knee, using the WOMAC C function subscale.

  12. Durability of Efficacy of a Single Intra-Articular (IA) Injection [ Time Frame: Baseline to the return of Baseline (NPRS pain with walking) ]
    Durability of efficacy of a single IA injection of CNTX-4975-05, as measured by the time from Baseline to the return of baseline pain with walking as measured by NPRS.

  13. Cumulative Responder Analysis [ Time Frame: Baseline through Week 12 ]
    Percent of patients with ≥ 30%, 50%, 70%, and 90% reduction in pain with walking (NPRS 0-10).



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 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.

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 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.

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): NCT03429049


  Show 33 Study Locations
Sponsors and Collaborators
Centrexion Therapeutics
Investigators
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Study Chair: Randall M. Stevens, MD Centrexion Therapeutics

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Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT03429049     History of Changes
Other Study ID Numbers: CNTX-4975i-OA-301
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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