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NCT06351852 · ClinicalTrials.gov registry record · Early Phase 1
Transdermal Administration by a Novel Wireless Iontophoresis Device
A Early Phase 1 study of Spinal Cord Injuries and Constipation, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT06351852 is a Early Phase 1 study of Spinal Cord Injuries and Constipation that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 2 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06351852, a Early Phase 1 study of Spinal Cord Injuries and Constipation, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE). The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis). The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially
Conditions Studied
Interventions
- DRUG Combination of Neostigmine and Glycopyrrolate
- DEVICE I-Box by Dynatronics
Study Locations (1)
New York
- James J. Peters Veterans Affairs Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2024-09-24 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06351852
The ClinicalTrials.gov registry entry for NCT06351852 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (97% lower). The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Combination of Neostigmine and Glycopyrrolate is the first listed.
NCT06351852 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06351852 about?
NCT06351852 is a clinical study titled "Transdermal Administration by a Novel Wireless Iontophoresis Device". Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in pers...
What is the current status of trial NCT06351852?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2022-03-22. Estimated completion is 2024-09-24.
What conditions does trial NCT06351852 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Constipation, Fecal Incontinence, Neurogenic Bowel.
What interventions are being tested in trial NCT06351852?
The interventions under investigation include: Combination of Neostigmine and Glycopyrrolate (DRUG), I-Box by Dynatronics (DEVICE).
Who is sponsoring clinical trial NCT06351852?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06351852 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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