Overview

STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis

Status:
Not yet recruiting

Trial end date:
2025-03-01

Target enrollment:

Participant gender:

Summary

The investigators propose to conduct a dose-escalation trial of an FDA-approved antiepileptic drug, lacosamide, added to opioid therapy in patients with chronic abdominal pain from chronic pancreatitis (CP). This pilot trial will test the feasibility of the study design and provide reassurance regarding the tolerability and safety of lacosamide used concomitantly with opioids in this patient population to reduce the condition known clinically as opioid-induced hyperalgesia (OIH).

Phase:

Phase 1

Details

Lead Sponsor:

Indiana University

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Treatments:

Lacosamide