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Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Osteoarthritis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04627038
Collaborator
(none)
202
Enrollment
40
Locations
2
Arms
11.3
Actual Duration (Months)
5.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to test the safety and efficacy of LY3556050 for the treatment of osteoarthritis 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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
202 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 LY3556050 for the Treatment of Osteoarthritis Pain
Actual Study Start Date :
Nov 12, 2020
Actual Primary Completion Date :
Oct 21, 2021
Actual Study Completion Date :
Oct 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3556050

LY3556050 given orally

Drug: LY3556050
Given orally
Placebo Comparator: Placebo

Placebo given orally

Drug: Placebo
Given orally

Outcome Measures

Primary Outcome Measures

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

    Change from Baseline in Average Pain Intensity as Measured by the NRS

Secondary Outcome Measures

  1. Change from Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale [Baseline, up to Week 8]

    Change from Baseline on the WOMAC® Pain Subscale

  2. Change from Baseline on the WOMAC® Stiffness Subscale [Baseline, up to Week 8]

    Change from Baseline on the WOMAC® Stiffness Subscale

  3. Change from Baseline on the WOMAC® Physical Function Subscale [Baseline, up to Week 8]

    Change from Baseline on the WOMAC® Physical Function Subscale

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

    Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change

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

    Change from Baseline for Worst Pain Intensity as Measured by NRS

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

    Change from Baseline on the VAS for Pain

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

    Change from Baseline on the Sleep Scale from the MOS Sleep Scale

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

    Total Amount of Rescue Medication

  9. Change from Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) [Baseline, up to Week 8]

    Change from Baseline on the EQ-5D-5L

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 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.

  • Have presence of index knee pain for >12 weeks at screening.

  • Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee.

  • 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 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 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.

  • Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare.

  • Have presence of surgical hardware or other foreign body in the index knee.

  • Have an unstable index joint (such as a torn anterior cruciate ligament).

  • Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period.

  • Have fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee.

  • Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.

  • Have clinical signs and symptoms of active knee infection or crystal disease of the index knee.

  • Have a history of infection in the index joint.

  • Have a history of arthritis due to crystals (e.g., gout, pseudogout).

  • Have pain or functional impairment due to ipsilateral hip osteoarthritis.

  • 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.

  • Have had any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Simon Williamson Clinic Birmingham Alabama United States 35211
2 Synexus- Chandler Chandler Arizona United States 85224
3 Synexus Clinical Research - Glendale Glendale Arizona United States 85306
4 Alliance for Multispecialty Research - Clinical Research Consortium Tempe Arizona United States 85281
5 Irvine Clinical Research Irvine California United States 92614
6 Artemis Institute for Clinical Research Riverside California United States 92503
7 Artemis Institute for Clinical Research San Diego California United States 92103
8 CMR of Greater New Haven Hamden Connecticut United States 06517
9 VIN-Julie Schwartzbard Aventura Florida United States 33180
10 Clinical Research of South Florida Coral Gables Florida United States 33134
11 Suncoast Research Group Miami Florida United States 33135
12 University of Miami Don Suffer Clinical Research Building Miami Florida United States 33136
13 New Horizon Research Center Miami Florida United States 33165
14 Renstar Medical Research Ocala Florida United States 34471
15 Synexus Clinical Research US, Inc - Orlando Orlando Florida United States 32806
16 Synexus Clinical Research - St. Petersburg Pinellas Park Florida United States 33781
17 Martin E. Hale M.D., P.A. Plantation Florida United States 33317
18 Synexus Clinical Research US, Inc. The Villages Florida United States 32162
19 Synexus Clinical Research Chicago Illinois United States 60602
20 Northwestern University Chicago Illinois United States 60611
21 Cotton O'Neil Clinic Topeka Kansas United States 66606
22 Boston Clinical Trials Boston Massachusetts United States 02131
23 ActivMed Practices and Research Methuen Massachusetts United States 01844
24 MedVadis Research Corporation Waltham Massachusetts United States 02451
25 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
26 StudyMetrix Research Saint Peters Missouri United States 63303
27 PharmQuest Greensboro North Carolina United States 27408
28 Synexus - Cincinnati Cincinnati Ohio United States 45236
29 Velocity Clinical Research, Cleveland Cleveland Ohio United States 44122
30 Aventiv Research Inc Columbus Ohio United States 43213
31 META Medical Research Institute Dayton Ohio United States 45432
32 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
33 Clinical Research Center of Reading,LLC Wyomissing Pennsylvania United States 19610
34 Coastal Carolina Research Center North Charleston South Carolina United States 29405
35 Cedar Health Research Dallas Texas United States 75251
36 Synexus - US San Antonio Texas United States 78229
37 Northwest Clinical Research Center Bellevue Washington United States 98007
38 Rainier Clinical Research Center Renton Washington United States 98057
39 Ponce Medical School Foundation Inc. Ponce Puerto Rico 716
40 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:
NCT04627038
Other Study ID Numbers:
  • 17593
  • H0P-MC-OA03
First Posted:
Nov 13, 2020
Last Update Posted:
Nov 10, 2021
Last Verified:
Nov 1, 2021
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:
Osteoarthritis

Study Results

No Results Posted as of Nov 10, 2021