Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back Pain

H0P-MC-BP03 -

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) which is a protocol to accelerate the development of new treatments for chronic pain.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Chronic Low-back Pain
What the trial is testing?
LY3556050
Could I receive a Placebo?
Yes
Enrollment Goal
153
Trial Dates
May 20, 2021 - Feb 9, 2022
How long will I be in the trial?
Your participation could last about 8 weeks and may include up to 5 visits to the study center.
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 a body mass index <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 lower back pain, except for rescue medication allowed in the study

  • Participants must have daily pain for at least 12 weeks

Participants Must Not:

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

  • Participants must not have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest

  • 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 had surgery for low back pain in the past 6 months

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