A phase 2a study of S-637880 in patients with neuropathic low back pain

JRCT ID: jRCT2031200418

Registered date:12/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neuropathic low back pain
• Date of first enrollment: 11/03/2021
• Target sample size: 160
• Study type: Interventional
• Intervention(s): Oral administration of S-637880 or placebo

Outcome(s)

• Primary Outcome: Changes from the baseline to 8 weeks administration in weekly mean of maximum daily pain intensity as measured by the Numerical Rating Scale

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Patients who meet the following criteria:
- Patients with chronic pain located in the posterior aspect of the trunk and between the twelfth rib and the inferior end of the gluteal fold
- Patients whose average daily pain intensity are 4 or higher on Visit 1
- Patients whose weekly mean of average daily pain intensity are 4 or higher and less than 10 for 7 days including Visit 2 (Day 1) on Visit 2

• Exclude criteria: Patients who are considered to have primary pain other than low back and leg pain or patients with neuropathic pain other than low back and leg pain

Related Information

• Primary Sponsor: Nagata - Tsutae