Study Summary
The main purpose of this study is to assess whether LY3857210 is safe and efficacious in relieving chronic low back pain (CLBP). 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.
Eligible Conditions
- Chronic Lower Back Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Baseline, Up to Week 12
Week 12
Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Week 8
Change from Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Change from Baseline for Worst Pain Intensity as Measured by NRS
Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L)
Change from Baseline on the Roland Morris Disability Questionnaire (RMDQ)
Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Change from Baseline on the Visual Analog Scale (VAS) for Pain
Total Amount of Rescue Medication
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
LY3857210
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
125 Total Participants · 2 Treatment Groups
Primary Treatment: LY3857210 · Has Placebo Group · Phase 2
LY3857210
Drug
Experimental Group · 1 Intervention: LY3857210 · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, up to week 12
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,465 Previous Clinical Trials
3,135,247 Total Patients Enrolled
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)Study DirectorEli Lilly and Company
1,257 Previous Clinical Trials
369,243 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Have a VAS pain value ≥40 and <95 during screening.
You have a body mass index (BMI) of less than 40 kg/m².
You have a history of low back pain as classified by the Quebec Task Force Category 1 through 3.
You 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.
You are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
You have low back pain for at least 3 months
Men, or women, are able to abide by reproductive and contraceptive requirements.
Who else is applying?
What state do they live in?
| Missouri | 50.0% |
| Washington | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "To be honest i was looking for a paid study, but when i seen this offer i got excited. I was suppose to have surgery in 2012 but got scared. Now i am so tired of the pain down my legs. My legs are starting to show discoloration. I have sever rupturing of the blood vessels in my legs it os painful. Please help."
- "Hey, how’s it in one Super Bowl Sandy I was in a car accident and I had back pain on both sides, knee pain, hip pain. I was treated with a chiropractor but that was just temporary. I’m trying to find a way to get this pain taken care of in my knee and my back. If you all can help me, that would be great. Thank you."
How many prior treatments have patients received?
| 0 | 50.0% |
| 3+ | 50.0% |
What site did they apply to?
| StudyMetrix Research | 100.0% |
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