Phase 2
N=153
Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back Pain
Chronic Low-back Pain
Bottom Line
View on ClinicalTrials.gov: NCT04874636 ↗Enrolled (actual)
153
Serious AEs
2.6%
Results posted
Nov 2023
Primary outcome: Primary: Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) — -1.69; -1.77 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY3556050 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) |
-1.69; -1.77 | — |
| SECONDARY Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ) |
-1.71; -1.92 | — |
| SECONDARY Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change |
2.83; 2.69 | — |
| SECONDARY Change From Baseline for Worst Pain Intensity as Measured by NRS |
-1.70; -2.00 | — |
| SECONDARY Change From Baseline on the Visual Analog Scale (VAS) for Pain |
-17.25; -25.15 | — |
| SECONDARY Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep |
0.17; 0.34 | — |
| SECONDARY Total Amount of Rescue Medication Use as Measured by Average Daily Dosage |
147.24; 182.22 | — |
| SECONDARY Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm) |
0.04; 0.04 | — |
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 (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
Eligibility Criteria
Inclusion Criteria
- Have a visual analog scale (VAS) pain value ≥40 and 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.
Data sourced from ClinicalTrials.gov (NCT04874636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.