A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of SP-103 in Subjects with Moderate to Severe Acute Lower Back Pain
Lower back pain (LBP) can be disruptive and uncomfortable. During an episode of LBP, even simple tasks involving lifting, bending, standing, and sitting can become difficult. Back pain is one of the most common reasons people see a doctor or miss work. About 8 out of 10 people experience LBP during their lifetime. This is why finding treatments for lower back pain is so important.
WHAT IS BEING RESEARCHED IN THIS STUDY?
This research study will evaluate the safety, tolerability, and pain-relieving ability of an investigational patch called SP-103.
SP-103 is designed to deliver more active medication, (lidocaine), than other products to the location of the pain. This may result in better control of pain for people with LBP.
WHO CAN PARTICIPATE IN THIS STUDY?
You may qualify to participate in this study if:
- You are 18 to 75 years old with moderate-to-severe lower back pain and/or muscular tenderness
- Your current episode of lower back pain has lasted for less than 3 months
- You have no history of lower back surgery
Additional requirements to participate must also be met. The staff at the study center will explain the complete list of requirements. Approximately 80 adults will participate in this research study. This study will be conducted at about 10 study sites in the United States.
FOR MORE INFORMATION ABOUT THIS STUDY: