Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
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
- 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
- Change from Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score [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 [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 [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 [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) [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) [Baseline, up to Week 8]
Change from Baseline on the EQ-5D-5L
- Total Amount of Rescue Medication [Baseline, up to Week 8]
Total Amount of Rescue Medication
Eligibility Criteria
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 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 taken for chronic pain conditions for the duration of the study.
-
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 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.
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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. Metformin Exception Limited dosages of metformin are allowed in this study. Additional exclusion criteria for participants taking metformin.
-
Have a history or presence of lactic acidosis.
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Have a history or presence of severe hepatic disease including cirrhosis.
-
Have uncontrolled or unstable congestive heart failure.
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Are taking carbonic anhydrase inhibitors if also taking metformin.
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Have had a change in metformin therapy in the last 12 weeks.
-
Have not maintained a stable dose of glucose-lowering agents other than metformin before randomization.
-
Are pregnant or breastfeeding.
-
Have fibromyalgia.
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 - Clinical Research Consortium | 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 | Clinical Research of South Florida | Coral Gables | Florida | United States | 33134 |
9 | Suncoast Research Group | Miami | Florida | United States | 33135 |
10 | University of Miami Don Suffer Clinical Research Building | Miami | Florida | United States | 33136 |
11 | New Horizon Research Center | Miami | Florida | United States | 33165 |
12 | Renstar Medical Research | Ocala | Florida | United States | 34470 |
13 | Synexus Clinical Research US, Inc - Orlando | Orlando | Florida | United States | 32806 |
14 | Synexus Clinical Research US, Inc. | Pinellas Park | Florida | United States | 33781 |
15 | Gold Coast Research | Plantation | Florida | United States | 33317 |
16 | Synexus Clinical Research US, Inc - Orlando | The Villages | Florida | United States | 32162 |
17 | Rocky Mountain Clinical Research | Idaho Falls | Idaho | United States | 83404 |
18 | Synexus Clinical Research US, Inc. | Chicago | Illinois | United States | 60602 |
19 | Northwestern University | Chicago | Illinois | United States | 60611 |
20 | NorthShore University HealthSystem | Skokie | Illinois | United States | 60077 |
21 | Boston Clinical Trials | Boston | Massachusetts | United States | 02131 |
22 | Joslin Diabetes Center | Boston | Massachusetts | United States | 02215 |
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 | Clinvest Research LLC | Springfield | Missouri | United States | 65807 |
28 | Synexus - Cincinnati | Cincinnati | Ohio | United States | 45236 |
29 | META Medical Research Institute | Dayton | Ohio | United States | 45432 |
30 | Altoona Center For Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
31 | FutureSearch Trials | Austin | Texas | United States | 78731 |
32 | Cedar Health Research | Dallas | Texas | United States | 75251 |
33 | Synexus - US | San Antonio | Texas | United States | 78229 |
34 | Northwest Clinical Research Center | Bellevue | Washington | United States | 98007 |
35 | Rainier Clinical Research Center | Renton | Washington | United States | 98057 |
36 | Ponce Medical School Foundation Inc. | Ponce | Puerto Rico | 00716 | |
37 | 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.- 17514
- H0P-MC-NP03