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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: Completed Phase 1 study of Spinal Cord Injuries and Constipation, sponsored by James J. Peters Veterans Affairs Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured from completion of adminstration to first bowel evacuation
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 |
What the finished NCT04671030 record still lists
NCT04671030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
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 NCT04671030's enrollment target sits among peer trials
6 183rd of 202 higher than 14 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries 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.
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