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NCT04671030 · ClinicalTrials.gov registry record · Phase 1
Use of a Prokinetic Agent as an Adjunct to Thrice Weekly Bowel Care After SCI
A Phase 1 study of Spinal Cord Injuries and Constipation, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04671030 is a 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 6 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04671030, a Phase 1 study of Spinal Cord Injuries and Constipation, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
To measure a baseline for each subject, an abdominal x-ray (KUB) was performed, the SCI Bowel Survey and Treatment Satisfaction Questionnaire (TSQM) were administered and the subject's weight determined. After all the baseline measurements were acquired, the subjects underwent transdermal screening with hair epilation to test their response to transdermal administration of NEO (0.07mg/kg) and GLY (0.014mg/kg). All subjects had a positive response (bowel movement within 60 minutes of drug administration) and received five more cycles of bowel care for two weeks. All subjects reported bowel evacuation during each session and some reported side effects like slight dry mouth, eye twitching, and cramping. These side effects lasted approximately 20-30 minutes in duration and there were no clinically significant changes in cardiopulmonary vital signs. Six subjects after completing two weeks of bowel care had an abdominal x-ray (KUB) done. Also, they were weighted and reassessed using the TSQM and bowel survey.
Conditions Studied
Interventions
- DRUG Neostigmine and Glycopyrrolate
- DEVICE Iontophoresis
Study Locations (1)
New York
- James J Peters VA Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2021-06-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04671030
The ClinicalTrials.gov registry entry for NCT04671030 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 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 (90% 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 3 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Neostigmine and Glycopyrrolate is the first listed.
NCT04671030 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04671030 about?
NCT04671030 is a clinical study titled "Use of a Prokinetic Agent as an Adjunct to Thrice Weekly Bowel Care After SCI". To measure a baseline for each subject, an abdominal x-ray (KUB) was performed, the SCI Bowel Survey and Treatment Satisfaction Questionnaire (TSQM) were administered and the subject's weight determined. After all the baseline measurements were acquired, the subjects underwent transdermal screening ...
What is the current status of trial NCT04671030?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-01-15. Estimated completion is 2021-06-03.
What conditions does trial NCT04671030 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Constipation, Neurogenic Bowel.
What interventions are being tested in trial NCT04671030?
The interventions under investigation include: Neostigmine and Glycopyrrolate (DRUG), Iontophoresis (DEVICE).
Who is sponsoring clinical trial NCT04671030?
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 NCT04671030 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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