Transdermal Administration of a Prokinetic Agent for Bowel Evacuation in Persons With SCI
Public ClinicalTrials.gov record NCT02370862. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Novel Application of Iontophoresis in the Transcutaneous Delivery of a Prokinetic Agent for the Promotion of Bowel Evacuation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most individuals with SCI. Previous studies have reported that the average time to complete a BC routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1 hour. In past studies, the investigators have shown that a medication called neostigmine (NEO) combined with a medication called glycopyrrolate (GLY) can increase bowel activity and thus, promote bowel movement. The investigators have successfully used this medication with traditional and novel methods of colonoscopic preparations, and have shown that it improves the quality of these preparations. In this Phase I, proof of concept pilot study, the investigators propose to study the effectiveness of this medicine when it is delivered through the skin. In order to make delivery more efficient, the investigators will be using a technique called iontophoresis, which uses a mild electric current to drive the drug through the surface of the skin. The instrument includes an electrode containing the active agent (delivers charge) and an oppositely charged electrode (receives charge) which will be placed on the surface of the skin. The study design will consist of a screening visit to determine each individual's response to a previously established IV dose of NEO and GLY, followed by a dose titration study (two visits) of iontophoresed NEO and GLY. Study visits will be separated by no less than 2 days and no more than 14 days. If this delivery method is shown to be effective, it may represent a way to vastly improve the clinical utility of this medication by allowing for needle-free self administration, and expanding the clinical indication to routine, at home bowel care.
Study identification
- NCT ID
- NCT02370862
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2013
- Primary completion
- Nov 30, 2016
- Completion
- Nov 30, 2016
- Last update posted
- Jul 5, 2026
2013 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| James J. Peters VA Medical Center | The Bronx | New York | 10468 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02370862, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 5, 2026 · Synced Sep 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02370862 live on ClinicalTrials.gov.