Chronic Pain, Low Back Pain
Conditions
Brief summary
The main purpose of this study is to test the safety and efficacy of study drug for the treatment of 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.
Interventions
DRUGLY4065967
Administered orally.
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 body mass index at screening of ≤40 kilograms per meter squared (kg/m²). * Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening
Exclusion criteria
* Are pregnant or breastfeeding * Have used a therapeutic injection to the spine in the 3 months prior to screening * Are using a spinal cord stimulator or dorsal root ganglion stimulator * Have ongoing complex regional pain syndrome or other concurrent medical conditions that could interfere with the evaluation of CLBP * Have a history of major spinal deformity, such as spondylolisthesis, spondylolysis, scoliosis, or spina bifida, that causes instability to the spine * Have an abnormal blood pressure (BP) systolic BP is greater than 140 millimeters mercury (\>140 mm Hg) and diastolic BP\>90 mm Hg at screening • Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | Baseline, Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Mean Overall Improvement as Measured by Patient Global Impression of Change (PGI-C) | Baseline, Week 8 |
| Change from Baseline in Worst Pain Intensity as Measured by NRS | Baseline, Week 8 |
| Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) | Baseline, Week 8 |
| Total Amount of Rescue Medication Used Daily During the Treatment Phase | Week 8 |
| Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L) | Baseline, Week 8 |
| Mean Change from Baseline to Endpoint for the Roland-Morris Disability Questionnaire (RMDQ) | Baseline, Week 8 |
Countries
Puerto Rico, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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
Outcome results
None listed