NCT05086289
Completed
Phase 2
Randomized Placebo-controlled Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Chronic Low Back Pain
Eli Lilly and Company28 sites in 2 countries159 target enrollmentStarted: October 25, 2021Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 159
- Locations
- 28
- Primary Endpoint
- Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4
Overview
Brief Summary
The purpose of this study is to test whether LY3526318 is efficacious and safe in relieving chronic low back pain (CLBP). 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
LY3526318
Experimental
Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.
Intervention: LY3526318 (Drug)
Placebo
Placebo Comparator
Participants received placebo orally, once daily, for 8-weeks treatment period.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4
Time Frame: Baseline, Week 4
The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Secondary Outcomes
- Total Amount of Rescue Medication Use as Measured by Average Daily Dosage(Week 8)
- Change From Baseline for Worst Pain Intensity as Measured by NRS(Baseline, Week 8)
- Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)(Baseline, Week 8)
- Change From Baseline on the Visual Analog Scale (VAS) for Pain(Baseline, Week 8)
- Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)(Baseline, Week 8)
- Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep(Baseline, Week 8)
- Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)(Baseline, Week 8)
- Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change(Baseline, Week 8)
Investigators
Study Sites (28)
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