RECRUITING

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

Conditions

Chronic Pain Chronic Pain Syndrome Chronic Pancreatitis Hyperalgesia Opioid Use Disorder Opioid-Related Disorders Opioid Dependence Chronic Abdominal Pain ERCP Pancreatic Surgery Pancreatitis Pancreatitis, chronic Pain Pancreatic Diseases Digestive System Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-03-17

Study Completion:2025-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05603702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. written informed consent and HIPAA authorization for release of personal health information; 2. ≥ 18 years old at the time of informed consent; 3. suspected (YELLOW 2 or 3) or definite diagnosis of CP, as per CPDPC PROCEED study definition with ongoing symptoms of abdominal pain; 4. patients must be maintained on an opioid (except methadone or suboxone) for 4 weeks prior to enrollment for treatment of abdominal pain related to pancreatitis; 5. ongoing symptoms of abdominal pain even with opioid use (VAS and BPI average score ≥4, at enrollment); 6. ECOG Performance Status of 0-2;(Oken et al., 1982) 7. ability to swallow and tolerate oral tablets; 8. females of childbearing potential must have a negative pregnancy test; 9. the following laboratory parameters must be met: WBC count ≥ 3.0 K/mm3, absolute neutrophil count ≥ 1.5 K/mm3, hemoglobin ≥ 9 g/dL, platelets ≥ 75 K/mm3, creatinine ≤ 1.5 mg/dl, bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN; normal PR interval on baseline 12-lead EKG.	1. subjects with indeterminate CP (YELLOW 1) as per PROCEED criteria; 2. treatment with any investigational agent within 30 days prior to registration, or concurrent participation in a clinical trial which involves another investigational agent; 3. rapidly escalating pain that requires parenteral (intravenous or intramuscular) opioid therapy within 30 days of enrollment; 4. known hypersensitivity/allergic reaction to lacosamide, carbamazepine or oxcarbazepine; 5. pregnant or breastfeeding; 6. patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs (other than gabapentin and pregabalin); 7. abdominal surgery or pain intervention (ERCP with sphincterotomy/stent/stone removal; celiac plexus block) within 90 days of enrollment. 8. hospitalization for pancreatitis exacerbation or pain management within 30 days of enrollment 9. patient who currently takes Suboxone or Methadone. 10. other factors which might explain the patient's ongoing symptoms, at the discretion of the enrolling physician. 11. history of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome. 12. primary pancreatic tumors- pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors. 13. pancreatic metastasis from other malignancies. 14. history of solid organ transplant, HIV/AIDS. 15. known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria). 16. participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in follow-up.

Inclusion Criteria

Exclusion Criteria

1. written informed consent and HIPAA authorization for release of personal health information;
2. ≥ 18 years old at the time of informed consent;
3. suspected (YELLOW 2 or 3) or definite diagnosis of CP, as per CPDPC PROCEED study definition with ongoing symptoms of abdominal pain;
4. patients must be maintained on an opioid (except methadone or suboxone) for 4 weeks prior to enrollment for treatment of abdominal pain related to pancreatitis;
5. ongoing symptoms of abdominal pain even with opioid use (VAS and BPI average score ≥4, at enrollment);
6. ECOG Performance Status of 0-2;(Oken et al., 1982)
7. ability to swallow and tolerate oral tablets;
8. females of childbearing potential must have a negative pregnancy test;
9. the following laboratory parameters must be met: WBC count ≥ 3.0 K/mm3, absolute neutrophil count ≥ 1.5 K/mm3, hemoglobin ≥ 9 g/dL, platelets ≥ 75 K/mm3, creatinine ≤ 1.5 mg/dl, bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN; normal PR interval on baseline 12-lead EKG.

1. subjects with indeterminate CP (YELLOW 1) as per PROCEED criteria;
2. treatment with any investigational agent within 30 days prior to registration, or concurrent participation in a clinical trial which involves another investigational agent;
3. rapidly escalating pain that requires parenteral (intravenous or intramuscular) opioid therapy within 30 days of enrollment;
4. known hypersensitivity/allergic reaction to lacosamide, carbamazepine or oxcarbazepine;
5. pregnant or breastfeeding;
6. patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs (other than gabapentin and pregabalin);
7. abdominal surgery or pain intervention (ERCP with sphincterotomy/stent/stone removal; celiac plexus block) within 90 days of enrollment.
8. hospitalization for pancreatitis exacerbation or pain management within 30 days of enrollment
9. patient who currently takes Suboxone or Methadone.
10. other factors which might explain the patient's ongoing symptoms, at the discretion of the enrolling physician.
11. history of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome.
12. primary pancreatic tumors- pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
13. pancreatic metastasis from other malignancies.
14. history of solid organ transplant, HIV/AIDS.
15. known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria).
16. participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in follow-up.

Contacts and Locations

Study Contact

Evan L Fogel, MD, MSc

CONTACT

317-944-2816

efogel@iu.edu

Fletcher A White, MS, PhD

CONTACT

317-274-5164

fawhite@iu.edu

Principal Investigator

Aynur Unalp-Arida, MD, PhD

STUDY_DIRECTOR

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

Study Locations (Sites)

Stanford University

Stanford, California, 94305

United States

Indiana University

Indianapolis, Indiana, 46202

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Ohio State University

Columbus, Ohio, 43210

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Indiana University

Aynur Unalp-Arida, MD, PhD, STUDY_DIRECTOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-17

Study Completion Date2025-03-31

Study Record Updates

Study Start Date2023-03-17

Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

Pancreatitis
Pancreatitis, chronic
Chronic pain
Pain
Pancreatic Diseases
Digestive System Diseases

Additional Relevant MeSH Terms

Chronic Pain
Chronic Pain Syndrome
Chronic Pancreatitis
Hyperalgesia
Opioid Use Disorder
Opioid-Related Disorders
Opioid Dependence
Chronic Abdominal Pain
ERCP
Pancreatic Surgery