Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Chronic Pain and Opioid Use Disorder, sponsored by Indiana University.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Dose-limiting toxicity of combination lacosamide and opioids. Patients will be examined and graded for subjective/objective evidence of developing grade 3 or 4 toxicities according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
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 |
What NCT05603702 shows while recruiting
NCT05603702 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (97% lower).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05603702's enrollment target sits among peer trials
24 264th of 301 higher than 37 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Managing Chronic Tendon Pain by Metformin
RECRUITING · Phase 1
-
Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling
RECRUITING · Phase 1
-
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
RECRUITING · Phase 1
-
Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis
RECRUITING · Phase 1
-
Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients
COMPLETED · Phase 1
-
Development and Evaluation of Computerized Chemosensory Based Orbitofrontal Networks Training for Treatment of Pain
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI