Actively Recruiting
STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis
Led by Indiana University · Updated on 2026-05-11
24
Participants Needed
5
Research Sites
210 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Be 18 years or older at the time of consent
- Have a suspected or definite diagnosis of chronic pancreatitis with ongoing abdominal pain
- Have used opioid medication (except methadone or suboxone) for at least 4 weeks for pancreatitis-related abdominal pain
- Have ongoing abdominal pain with a pain score of 4 or higher on VAS and BPI at enrollment
- Have an ECOG Performance Status of 0 to 2
- Be able to swallow and tolerate oral tablets
- Females of childbearing potential must have a negative pregnancy test
- Meet required laboratory values for blood counts, kidney and liver function, and have a normal PR interval on baseline EKG
You will not qualify if you...
- Have indeterminate chronic pancreatitis as per PROCEED criteria
- Have received any investigational treatment within 30 days before registration or participate in another investigational trial
- Have rapidly increasing pain requiring intravenous or intramuscular opioids within 30 days before enrollment
- Have known allergy to lacosamide, carbamazepine, or oxcarbazepine
- Are pregnant or breastfeeding
- Have epilepsy or currently take antiepileptic drugs other than gabapentin or pregabalin
- Have had abdominal surgery or pain intervention within 90 days before enrollment
- Have been hospitalized for pancreatitis exacerbation or pain management within 30 days before enrollment
- Currently take Suboxone or Methadone
- Have other conditions explaining the symptoms as judged by the physician
- Have a history of autoimmune or traumatic pancreatitis or acute necrotizing pancreatitis with suspected disconnected duct syndrome
- Have pancreatic tumors or metastases from other cancers
- Have a history of solid organ transplant or HIV/AIDS
- Have isolated pancreatic exocrine insufficiency without other inclusion criteria
- Have medical or psychiatric illnesses or substance abuse that may affect study participation or treatment tolerance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Stanford University
Stanford, California, United States, 94305
Active, Not Recruiting
2
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
4
Ohio State University
Columbus, Ohio, United States, 43210
Active, Not Recruiting
5
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
E
Evan L Fogel, MD, MSc
CONTACT
F
Fletcher A White, MS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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