NCT05603702 STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief 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).

Eligibility Criteria

Inclusion 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 inter

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.