Clincosm LogoSign in Get a demo

Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT05086289
Collaborator
(none)
159
Enrollment
31
Locations
2
Arms
7.7
Actual Duration (Months)
5.1
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test whether LY3526318 is efficacious in relieving chronic low back pain (CLBP). 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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized Placebo-controlled Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Chronic Low Back Pain
Actual Study Start Date :
Oct 25, 2021
Actual Primary Completion Date :
Jun 17, 2022
Actual Study Completion Date :
Jun 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3526318

LY3526318 administered orally

Drug: LY3526318
Administered orally
Placebo Comparator: Placebo

Placebo administered orally

Drug: Placebo
Administered orally

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Change from Baseline on the Roland Morris Disability Questionnaire (RMDQ) [Baseline, up to Week 8]

  2. Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change [Baseline, up to Week 8]

  3. Change from Baseline for Worst Pain Intensity as Measured by NRS [Baseline, up to Week 8]

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

  5. Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [Baseline, up to Week 8]

  6. Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) [Baseline, up to Week 8]

  7. Total Amount of Rescue Medication [Baseline, up to Week 8]

    Total Amount of Rescue Medication

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 medications taken for chronic pain conditions for the duration of the study.

  • Are at 18 years old or older at the time consent is signed.

  • 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.

  • Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

  • 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 had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.

  • Have fibromyalgia

  • Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).

  • 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 compression fracture.

  • Have had a recent major trauma (within 6 months of baseline).

  • Have a history of low back pain as classified by the Quebec Task Force categories 4 through 11.

  • Are using a spinal cord stimulator or dorsal root ganglion stimulator.

  • Are pregnant or breastfeeding.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Synexus- Chandler Chandler Arizona United States 85224
2 Synexus Clinical Research - Glendale Glendale Arizona United States 85306
3 Alliance for Multispecialty Research, LLC Tempe Tempe Arizona United States 85281
4 Artemis Institute for Clinical Research Riverside California United States 92503
5 Artemis Institute for Clinical Research San Diego California United States 92103
6 CMR of Greater New Haven Hamden Connecticut United States 06517
7 VIN-Julie Schwartzbard Aventura Florida United States 33180
8 Suncoast Research Group Miami Florida United States 33135
9 New Horizon Research Center Miami Florida United States 33165
10 Renstar Medical Research Ocala Florida United States 34470
11 Synexus Clinical Research US, Inc - Orlando Orlando Florida United States 32806
12 Synexus Clinical Research US, Inc. Pinellas Park Florida United States 33781
13 Synexus Clinical Research US, Inc. The Villages Florida United States 32162
14 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
15 Synexus Clinical Research US, Inc. Chicago Illinois United States 60602
16 Northwestern University Chicago Illinois United States 60611
17 Boston Clinical Trials Boston Massachusetts United States 02131
18 ActivMed Practices and Research Methuen Massachusetts United States 01844
19 MedVadis Research Corporation Waltham Massachusetts United States 02451
20 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
21 StudyMetrix Research Saint Peters Missouri United States 63303
22 Clinvest Research LLC Springfield Missouri United States 65807
23 Synexus - Cincinnati Cincinnati Ohio United States 45236
24 META Medical Research Institute Dayton Ohio United States 45432
25 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
26 FutureSearch Trials Austin Texas United States 78731
27 Synexus - US San Antonio Texas United States 78229
28 Northwest Clinical Research Center Bellevue Washington United States 98007
29 Rainier Clinical Research Center Renton Washington United States 98057
30 Ponce Medical School Foundation Inc. Ponce Puerto Rico 00716
31 Latin Clinical Trial Center San Juan Puerto Rico 00909

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05086289
Other Study ID Numbers:
  • 17515
  • H0P-MC-BP02
First Posted:
Oct 20, 2021
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Back Pain
Low Back Pain

Study Results

No Results Posted as of Jul 13, 2022