Efficacy and tolerability of ODM-111 in chronic pain due to diabetic peripheral neuropathy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513595-17-00

Acronym

3133004

Enrollment

203

Registered

2024-10-21

Start date

Unknown

Completion date

2024-10-28

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHRONIC PAIN DUE TO DIABETIC PERIPHERAL NEUROPATHY

Brief summary

The primary efficacy endpoint is the change from baseline to week 6 in the weekly average of daily pain intensity (average over the previous 24 hours) on the 11-point numeric rating scale (NRS), as reported in the daily eDiary.

Interventions

DRUGPara-Tabs 500 mg tabletti

DRUGODM-111 Placebo

DRUGODM-111

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the change from baseline to week 6 in the weekly average of daily pain intensity (average over the previous 24 hours) on the 11-point numeric rating scale (NRS), as reported in the daily eDiary.	—

Countries

Bulgaria, Czechia, Germany, Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026