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

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 17, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Chronic PainChronic Pain SyndromeChronic PancreatitisHyperalgesiaOpioid Use DisorderOpioid-Related DisordersOpioid DependenceChronic Abdominal PainERCPPancreatic Surgery
Interventions
DRUG

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

Trial Locations (5)

15213

RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

43210

RECRUITING

Ohio State University, Columbus

46202

RECRUITING

Indiana University, Indianapolis

55905

RECRUITING

Mayo Clinic, Rochester

94305

COMPLETED

Stanford University, Stanford

All Listed Sponsors
collaborator

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

NIH

lead

Indiana University

OTHER