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A Study to Compare Five Different Treatment Regimens of CNTX-4975 for Participants With Chronic, Moderate-to-Severe Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT03661996
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE September 25, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Determination of Optimal Procedure for Administering CNTX-4975-05 with Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction [ Time Frame: Study Start to Day 3 after Treatment ]
Equally-weighted, combined score calculated for the 5 treatment regimens by assessing pain using 0-4 scale of none, mild, moderate, moderately severe, and severe; (2) assessment of the participant's satisfaction with the treatment regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied); and (3) assessment of the investigator's satisfaction with the treatment regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03661996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • OMERACT-OARSI Percent of Responders after a Single Injection into the Index Knee [ Time Frame: Study Start to Week 8 ]
    Percent of responders based on the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responders at Week 8 for participants with a single CNTX-4975-05 joint injection (index knee, moderate to severe pain index knee, pain not >3 for contralateral knee).
  • OMERACT-OARSI Percent of Responders after a Single Injection into both Knees [ Time Frame: Study Start to Week 8 ]
    Percent of OMERACT-OARSI responders at Week 8 for participants with bilateral knee injections of CNTX-4975-05 (index knee, moderate to severe pain index knee, both knees meeting OMERACT-OARSI responder criteria).
  • OMERACT-OARSI Percent of Responders after a Single Injection into the Index Knee [ Time Frame: Study Start to Week 8 ]
    Percent of OMERACT-OARSI responders at Week 8 for participants with a single CNTX-4975-05 joint injection (population with index knee, moderate to severe pain index knee, non-index knee with partial joint replacement [PJR]/ total joint replacement [TJR]).
  • KOOS (Knee Injury and Osteoarthritis Outcome Score) [ Time Frame: Study Start to Week 8 ]
    For each of the 3 types of participants, the absolute change; the number of participants who have ≥30%, ≥50%, ≥70%, or ≥90% improvement at week 8; and on the 5 subscales (pain, other symptoms, activities of daily living, sports and recreation, quality of life) of the KOOS at Week 8.
  • Participant Satisfaction of Treatment Rated Using Questionnaire [ Time Frame: Study Start to Week 8 ]
    Assess subject satisfaction of treatment with CNTX-4975-05 IA injection for each of the 3 types of participants, and all participants in the trial, on a scale of 1 (completely dissatisfied) to 7 (completely satisfied) at week 8.
  • Participant Satisfaction of Partial Joint Replacement/Total Joint Replacement (PJR/TJR) Rated Using Questionnaire [ Time Frame: Study Start to Week 8 ]
    For subject with PJR/TJR, assess satisfaction with CNTX-4975-05 IA injection versus satisfaction with the knee with a PJR/TJR on a scale of 1 (completely dissatisfied) to 7 (completely satisfied).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare Five Different Treatment Regimens of CNTX-4975 for Participants With Chronic, Moderate-to-Severe Osteoarthritis Pain
Official Title  ICMJE 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
Brief Summary 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 1.0 mg 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Drug: CNTX-4975-05
    Osteoarthritis (OA) intra-articular injection 1 mg CNTX-4975-05
    Other Name: trans-capsaicin
  • Drug: Lidocaine without epinephrine
    15 mL lidocaine intra-articular injection
  • Device: ElastoGel
    Cooling Device
  • Device: Breg Ice Water Pump
    Cooling Device
Study Arms  ICMJE
  • Experimental: Breg Cooling Control Group
    Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump.
    Interventions:
    • Drug: CNTX-4975-05
    • Drug: Lidocaine without epinephrine
    • Device: Breg Ice Water Pump
  • Experimental: Gel Pack Cooling Group
    Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
    Interventions:
    • Drug: CNTX-4975-05
    • Drug: Lidocaine without epinephrine
    • Device: ElastoGel
  • Experimental: Shortened Gel Pack Cooling Group
    Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
    Interventions:
    • Drug: CNTX-4975-05
    • Drug: Lidocaine without epinephrine
    • Device: ElastoGel
  • Experimental: Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine
    Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
    Interventions:
    • Drug: CNTX-4975-05
    • Drug: Lidocaine without epinephrine
    • Device: ElastoGel
  • Experimental: Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine
    Subject receives 1% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
    Interventions:
    • Drug: CNTX-4975-05
    • Drug: Lidocaine without epinephrine
    • Device: ElastoGel
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
850
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (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)
  • 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.
  • 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.
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: Study Manager 617-837-6911 info@centrexion.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03661996
Other Study ID Numbers  ICMJE CNTX-4975i-OA-303
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centrexion Therapeutics
Study Sponsor  ICMJE Centrexion Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Randall M. Stevens, MD Centrexion Therapeutics Corp
PRS Account Centrexion Therapeutics
Verification Date March 2019

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