Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain

H0P-MC-BP01 -

This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of chronic low back pain.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Chronic Low-back Pain
What the trial is testing?
LY3016859
Could I receive a Placebo?
Yes
Enrollment Goal
149
Trial Dates
Aug 25, 2020 - Oct 4, 2021
How long will I be in the trial?
The study will last about 26 weeks and may include up to 8 visits.
Trial Phase
II

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have daily pain for at least 12 weeks

  • Participants must have a body mass index of <40 kilograms per meter squared (kg/m²)

  • Participants must be willing to maintain any non-drug pain relieving therapies (for example, physical therapy) and not start any new non-drug pain-relieving therapies during the study

  • Participants must be willing to stop all pain medications for low back pain, except for rescue medication allowed in the study

Participants Must Not:

  • Participants must not have surgery planned during the study for any reason

  • Participants must not have had cancer within 2 years, except for certain types of skin cancer (cutaneous basal cell or squamous cell carcinoma) surgically removed

  • Participants must not have an intolerance to acetaminophen or paracetamol

  • Participants must not have a history of alcohol or drug disorder within 2 years

  • Participants must not have had an injection (botulinum toxin or corticosteroids) for back pain within 3 months of screening

  • Participants must not have had surgery for low back pain in the past 6 months

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