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Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT04707157
Recruitment Status : Not yet recruiting
First Posted : January 13, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE January 12, 2021
First Posted Date  ICMJE January 13, 2021
Last Update Posted Date January 20, 2021
Estimated Study Start Date  ICMJE January 29, 2021
Estimated Primary Completion Date January 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline, up to Week 8 ]
Change from Baseline in Average Pain Intensity as Measured by the NRS
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • Change from Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline in the BPI-SF Total Interference Score
  • Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
  • Change from Baseline for Worst Pain Intensity as Measured by NRS [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline for Worst Pain Intensity as Measured by NRS
  • Change from Baseline on the Visual Analog Scale (VAS) for Pain [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline on the Visual Analog Scale (VAS) for Pain
  • Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline on the Sleep Scale from the MOS Sleep Scale
  • Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline on the EQ-5D-5L
  • Total Amount of Rescue Medication [ Time Frame: Baseline, up to Week 8 ]
    Total Amount of Rescue Medication
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 Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain
Official Title  ICMJE Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Brief Summary This study is being done to test the safety and efficacy of the study drug LY3556050 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol (H0P-MC-CPMP) which is a protocol to accelerate the development of new treatments for chronic pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Peripheral Neuropathic Pain
Intervention  ICMJE
  • Drug: LY3556050
    given orally
  • Drug: Placebo
    given orally
Study Arms  ICMJE
  • Experimental: LY3556050
    LY3556050 given orally
    Intervention: Drug: LY3556050
  • Placebo Comparator: Placebo
    Placebo given orally
    Intervention: Drug: Placebo
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2021)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 21, 2022
Estimated Primary Completion Date January 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
  • Have a history of daily pain for at least 12 weeks based on participant report or medical history.
  • Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
  • Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
  • Are willing to discontinue all pain medications, as required per protocol, except permitted rescue medication per protocol.
  • Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
  • Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
  • Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
  • Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

  • Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
  • Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
  • Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
  • Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
  • Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
  • Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
  • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
  • Have a positive human immunodeficiency virus (HIV) test result at screening.
  • Have an intolerance to acetaminophen or paracetamol or any of its excipients.
  • Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
  • Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
  • Have known hereditary motor, sensory or autonomic neuropathies.
  • Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
  • Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.
  • Are taking metformin therapy.
  • Are pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04707157
Other Study ID Numbers  ICMJE 17514
H0P-MC-NP03 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
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
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date January 15, 2021

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