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Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04874636
Recruitment Status : Recruiting
First Posted : May 6, 2021
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This study is being done to test the safety and efficacy of the study drug LY3556050 for the treatment of chronic low back 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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Drug: LY3556050 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : February 16, 2022
Estimated Study Completion Date : February 16, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3556050
LY3556050 administered orally
 Drug: LY3556050
Administered orally
Placebo Comparator: Placebo
Placebo administered orally
 Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline for Average Pain Intensity as Measured by the NRS


Secondary Outcome Measures :
  1. Change from Baseline on the Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline on the RMDQ

  2. 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

  3. 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

  4. Change from Baseline on the Visual Analog Scale (VAS) for Pain [ Time Frame: Baseline, up to Week 8 ]
    Change from Baseline on the VAS for Pain

  5. 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

  6. Total Amount of Rescue Medication [ Time Frame: Baseline, up to Week 8 ]
    Total Amount of Rescue Medication

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 value of ≤30 on the pain catastrophizing scale.
  • 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 medications taken for chronic pain conditions for the duration of the study.
  • Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation.
  • Have a history of low back pain as classified by the Quebec Task Force Category 1 through 3.
  • Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 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.
  • There is an inability to rule out other causative or confounding sources of pain in the primary condition under study.
  • Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
  • Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
  • Have congenital QT prolongation or QT interval corrected for heart rate using Fridericia's formula (QTcF) interval measurement >450 milliseconds (msec) for male participants, >470 msec for female participants, or >480 msec for participants with bundle branch block.
  • Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
  • Have a positive human immunodeficiency virus (HIV) test result at screening.
  • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
  • 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 used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months prior to starting the washout period.
  • Have history of or current osteoporotic compression fracture.
  • Have had a recent major trauma (within 6 months of baseline).
  • Have had surgical intervention for the treatment of low back pain in the past 6 months.
  • 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.
Contacts and Locations
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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): NCT04874636


Contacts
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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

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT) - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04874636    
Other Study ID Numbers: 17595
H0P-MC-BP03 ( Other Identifier: Eli Lilly and Company )
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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 European Union (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/

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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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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations