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NCT05603702 · ClinicalTrials.gov registry record · Phase 1
STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis
A Phase 1 study of Chronic Pain and Opioid Use Disorder, sponsored by Indiana University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 5
- Study locations
NCT05603702 is a Phase 1 study of Chronic Pain and Opioid Use Disorder that is actively recruiting participants, run by Indiana University. The registered enrollment target is 24 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT05603702, a Phase 1 study of Chronic Pain and Opioid Use Disorder, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 5
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Lacosamide
Study Locations (5)
California
- Stanford University - Stanford
Indiana
- Indiana University - Indianapolis
Minnesota
- Mayo Clinic - Rochester
Ohio
- Ohio State University - Columbus
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-03-17 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05603702
The ClinicalTrials.gov registry entry for NCT05603702 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (97% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Chronic Pain appearing as the primary indexed condition, and to 1 intervention - of which Lacosamide is the first listed.
NCT05603702 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Indiana, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05603702 about?
NCT05603702 is a clinical study titled "STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis". 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 regar...
What is the current status of trial NCT05603702?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-03-17. Estimated completion is 2026-03-31.
What conditions does trial NCT05603702 study?
This clinical trial studies the following conditions: Chronic Pain, Opioid Use Disorder, Opioid-Related Disorders, Chronic Pancreatitis, Opioid Dependence.
What interventions are being tested in trial NCT05603702?
The interventions under investigation include: Lacosamide (DRUG).
Who is sponsoring clinical trial NCT05603702?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05603702 being conducted?
This trial has 5 study locations across California, Indiana, Minnesota, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.