Clinical Research Directory
Browse clinical research sites, groups, and studies.
STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis
Sponsor: Indiana University
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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2023-03-17
Completion Date
2026-03-31
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Lacosamide
Study Visit 1: Baseline study assessments will be made and questionnaires completed in person, on day 0. Drug treatment days will then occur on days 1-7. Study Visit 2: Following completion of the 7-day drug treatment period, participants will have a face-to-face clinic visit on day 8 (with a 3 day grace period), where similar assessments and questionnaires will again be completed. Participants will return all unused drug at this visit, for disposal and to monitor compliance. A follow-up phone visit will occur on day 21 (with a 3 day window) to assess for adverse events and medication changes
Locations (5)
Stanford University
Stanford, California, United States
Indiana University
Indianapolis, Indiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Ohio State University
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States