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

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

51

The median age (range) was 60.0 years (20 to 74) in the S-637880 group and 62.5 years (41 to 74) in the placebo group. Most participant had chronic low back pain whose cause was identified; 92.0% (23/25) in the S-637880 group and 88.5% (23/26) in the placebo group.

This study was prematurely terminated at all study sites on the basis of a treatment related serious treatment emergent adverse event (agranulocytosis) and a treatment-related non-serious treatment emergent adverse event (white blood cell count decreased) reported in 1 participant each in the S-637880 group in this study. A total of 51 participants had been randomized at termination versus planned 160 participants. Of the 51 randmized participants (25 in the S-637880 group and 26 in the placebo group), 21 completed the study (8 in the S-637880 group and 13 in the placebo group) and 30 discontinued the study (17 in the S-637880 group and 13 in the placebo group).

No deaths were reported during the study. One serious treatment emergent adverse event, agranulocytosis, was reported in 1 of 25 participants in the S-637880 group (4.0%). Three treatment emergent adverse events leading to discontinuation of the study intervention (agranulocytosis, alanine aminotransferase, and aspartate aminotransferase increased) were reported in 2 of 25 participants of the S-637880 group (8.0%). A total of 13 treatment emergent adverse events were reported in 6 of 25 participants of the S-637880 group (24.0%), while 6 TEAEs were reported in 4 of 26 participants of the placebo group (15.4%). Of these treatment emergent adverse events, 2 reported in 2 of 25 participants of the S-637880 group (8.0%, agranulocytosis and white blood cell count decreased) and 2 reported in 1 of 26 participants of the placebo group (3.8%, blood glucose increased and urinary occult blood positive) were treatment related.

No significant difference between the S-637880 group and the placebo group in the amount of change from baseline in the mean weekly NRS score of worst daily leg pain at Week 8 after the start of study drug administration was observed.

Since this study was prematurely terminated at all study sites, the efficacy and safety could not be fully evaluated.

Oct. 31, 2022

No

Not applicable

https://jrct.mhlw.go.jp/latest-detail/jRCT2031200418

Nagata - Tsutae

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department - -

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Complete

Mar. 11, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

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

Both

Neuropathic low back pain

Oral administration of S-637880 or placebo

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

+81-3-5543-0196

Feb. 17, 2021

none