Spinal Cord InjuryEarly Phase 1NCT02370862
Transdermal Administration of a Prokinetic Agent for Bowel Evacuation in Persons With SCI
A Early Phase 1 study testing Neostigmine and Glycopyrrolate in people with Spinal Cord Injury and Neurogenic Bowel, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury, Neurogenic Bowel
- What is being tested?
- Neostigmine and Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incomplete or complete SCI,
- Tetraplegia or paraplegia,
- Excess time for bowel evacuation (> 60 minutes per bowel training session)
Who cannot join
- Previous adverse reaction or hypersensitivity to electrical stimulation,
- Known sensitivity to neostigmine or glycopyrrolate,
- Do not require additional bowel care or have "normal bowel function",
- Blockage Bowel or Bladder,
- Myocardial infarction in the past 6 months,
- Blood pressure of 160/100mmHg or higher with or without being on 3 or more different classes of anti-hypertensive medications
Show all 18Show fewer
- Organ damage (heart \& kidney damage) and/or transient ischemic attack (TIA)- cerebrovascular accident (CVA) as a result of hypertension
- Known past history of coronary artery disease or bradyarrythmia,
- Active respiratory disease,
- Known history of asthma during lifetime or recent (within 3 months) respiratory infections.
- Adrenal insufficiency,
- Pregnancy or potential for pregnancy,
- Lactating/nursing females,
- Slow heart rate (<45 bpm)
- Use of any antibiotic in the past 7 days,
- Use of medications known to affect the respiratory system,
- Use of medications known to alter airway caliber,
- Concurrent participation in other clinical trials (within 30 days).
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: A Novel Application of Iontophoresis in the Transcutaneous Delivery of a Prokinetic Agent for the Promotion of Bowel Evacuation
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.
Read the detailed description
In this Phase I, proof of concept pilot study, we propose to study the safety and efficacy of transcutaneous neostigmine and glycopyrrolate facilitated by iontophoresis. 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.
Screening Bowel Evacuation Study, Part 1: Visit 1 (30 Subjects with SCI):
A previously determined efficacious dose of IV neostigmine (0.03 mg/kg IV NEO) with glycopyrrolate (0.006 mg/kg GLY) will be administered during the first study visit to determine subject responsiveness to the known effective mode of administration. Irregardless of excess weight, the maximum dose of neostigmine and glycopyrrolate (NG) is limited to 10.0 mg and GLY to 2.0 mg. If the subject responds to the IV NEO, subsequent study visits to determine the effective dose of transcutaneous NEO and GLY will be performed. Subjects will be asked to arrive at the Spinal Cord Research Center at the James J. Peters Veteran Affairs Medical Center (JJP VAMC) (Room 7A-13) on the day of their scheduled study visits. Heart rate (continuous ecg), blood pressure, airway resistance (Impulse Oscillometry, IOS), signs and symptoms, and artificial bowel evacuation will be monitored throughout the study visit. Subjects will remain in this position until a bowel movement occurs, or for the next 60 minutes of the study. Subjects will be monitored for a minimum of 1.5 hours post drug, and until they reach ± 10% of their baseline heart rate (continuous 3 lead ECG) and airway caliber as measured by IOS.
Transcutaneous Bowel Evacuation Study, Part 2: Visits 2-3 (up to 25Subjects with SCI):
The same subjects who participated in Visit 1 who demonstrated a response to the IV NEO and GLY will participate in visits 2-3. Due to probable inter-subject variability of drug response to the doses of neostigmine being administered, subjects will receive increasing doses of iontophoresed neostigmine on separate days over 2 study visits to determine the most effective average dose. We will administer the transcutaneous NEO and GLY facilitated by iontophoresis. The dosages for Visits 2-3 are as follows: Visit 2: 0.05 mg/kg NEO and 0.01 mg/kg GLY, Visit 3: 0.07 mg/kg NEO and 0.14 mg/kg GLY. Irregardless of excess weight, the maximum dose of NG is limited to 10.0 mg and GLY to 2.0 mg. Heart rate (continuous ecg), blood pressure, airway resistance (Impulse Oscillometry, IOS) signs and symptoms, and artificial bowel evacuation will be monitored throughout the study visit as described in Table 1. Subjects will be asked to arrive at the Spinal Cord Research Center at the JJP VAMC (Room 7A-13) on the day of their scheduled study visits. Subjects will remain in this position until a bowel movement occurs, or for the next 90 minutes of the study. Subjects will be monitored for a minimum of 90 minutes post drug, and until they reach ± 10% of their baseline heart rate (continuous 3 lead ECG) and airway caliber as measured by IOS.
- Conditions
- Spinal Cord Injury, Neurogenic Bowel
- Being tested
- Neostigmine and Glycopyrrolate
- Keywords
- Spinal Cord Injury, Neurogenic Bowel, Bowel Evacuation, Gut Motility
- Medical subject headings
- Spinal Cord Injuries, Neurogenic Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine and GlycopyrrolateDrug
| Study group | Role | What they receive |
|---|---|---|
| Bowel Evacuation Study with NEO and GLY | Experimental | 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. Receives: Drug: Neostigmine and Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological Responses to Study Drugs (quantified by the presence and strength of biological responses (changes in bowel sounds, heart rate and airway resistance and bowel movement occurrence)
We aim to determine the efficacy of transcutaneous (TC) neostigmine (NEO) with glycopyrrolate (GLY) delivered via iontophoresis in promoting bowel movement in persons with chronic SCI. This will be quantified by the presence and strength of biological responses (changes in bowel sounds, heart rate and airway resistance and bowel movement occurrence).
Measured: 6 months
Secondary outcomes (1)
Safety of Study Medication (quantified through monitoring of side effects during study visits and through patient self report as measured by the Treatment Satisfaction Questionnaire)
We aim to determine the safety and tolerability of TC NEO and GLY in persons with SCI when used to promote bowel movement. This will be quantified through monitoring of side effects during study visits and through patient self report as measured by the Treatment Satisfaction Questionnaire.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Dr. Mark Korsten, James J. Peters Veterans Affairs Medical Center
- Investigators
- Mark A Korsten, MD, Principal investigator, James J. Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370862
- Sponsor's protocol ID
- KOR-13-02
- Other IDs
- CDMRP- SC180166
- Status last verified
- Jul 2026
- First submitted
- 19 Feb 2015
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Application of Iontophoresis in the Transcutaneous Delivery of a Prokinetic Agent for the Promotion of Bowel Evacuation
- ClinicalTrials.gov ID
- NCT02370862
- Acronym / sponsor ID
- KOR-13-02
- Conditions
- Spinal Cord Injury, Neurogenic Bowel
- Keywords
- Spinal Cord Injury, Neurogenic Bowel, Bowel Evacuation, Gut Motility
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- Feb 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this Phase I, proof of concept pilot study, we propose to study the safety and efficacy of transcutaneous neostigmine and glycopyrrolate facilitated by iontophoresis. 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.
Screening Bowel Evacuation Study, Part 1: Visit 1 (30 Subjects with SCI):
A previously determined efficacious dose of IV neostigmine (0.03 mg/kg IV NEO) with glycopyrrolate (0.006 mg/kg GLY) will be administered during the first study visit to determine subject responsiveness to the known effective mode of administration. Irregardless of excess weight, the maximum dose of neostigmine and glycopyrrolate (NG) is limited to 10.0 mg and GLY to 2.0 mg. If the subject responds to the IV NEO, subsequent study visits to determine the effective dose of transcutaneous NEO and GLY will be performed. Subjects will be asked to arrive at the Spinal Cord Research Center at the James J. Peters Veteran Affairs Medical Center (JJP VAMC) (Room 7A-13) on the day of their scheduled study visits. Heart rate (continuous ecg), blood pressure, airway resistance (Impulse Oscillometry, IOS), signs and symptoms, and artificial bowel evacuation will be monitored throughout the study visit. Subjects will remain in this position until a bowel movement occurs, or for the next 60 minutes of the study. Subjects will be monitored for a minimum of 1.5 hours post drug, and until they reach ± 10% of their baseline heart rate (continuous 3 lead ECG) and airway caliber as measured by IOS.
Transcutaneous Bowel Evacuation Study, Part 2: Visits 2-3 (up to 25Subjects with SCI):
The same subjects who participated in Visit 1 who demonstrated a response to the IV NEO and GLY will participate in visits 2-3. Due to probable inter-subject variability of drug response to the doses of neostigmine being administered, subjects will receive increasing doses of iontophoresed neostigmine on separate days over 2 study visits to determine the most effective average dose. We will administer the transcutaneous NEO and GLY facilitated by iontophoresis. The dosages for Visits 2-3 are as follows: Visit 2: 0.05 mg/kg NEO and 0.01 mg/kg GLY, Visit 3: 0.07 mg/kg NEO and 0.14 mg/kg GLY. Irregardless of excess weight, the maximum dose of NG is limited to 10.0 mg and GLY to 2.0 mg. Heart rate (continuous ecg), blood pressure, airway resistance (Impulse Oscillometry, IOS) signs and symptoms, and artificial bowel evacuation will be monitored throughout the study visit as described in Table 1. Subjects will be asked to arrive at the Spinal Cord Research Center at the JJP VAMC (Room 7A-13) on the day of their scheduled study visits. Subjects will remain in this position until a bowel movement occurs, or for the next 90 minutes of the study. Subjects will be monitored for a minimum of 90 minutes post drug, and until they reach ± 10% of their baseline heart rate (continuous 3 lead ECG) and airway caliber as measured by IOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bowel Evacuation Study with NEO and GLY | Experimental | Drug: Neostigmine and GlycopyrrolateThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Incomplete or complete SCI,
- Tetraplegia or paraplegia,
- Excess time for bowel evacuation (> 60 minutes per bowel training session)
Key exclusion criteria (18 listed)
- Previous adverse reaction or hypersensitivity to electrical stimulation,
- Known sensitivity to neostigmine or glycopyrrolate,
- Do not require additional bowel care or have "normal bowel function",
- Blockage Bowel or Bladder,
- Myocardial infarction in the past 6 months,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neostigmine and Glycopyrrolate | Drug | Bowel Evacuation Study with NEO and GLY |
Primary outcome
Biological Responses to Study Drugs (quantified by the presence and strength of biological responses (changes in bowel sounds, heart rate and airway resistance and bowel movement occurrence)
Time frame: 6 months
We aim to determine the efficacy of transcutaneous (TC) neostigmine (NEO) with glycopyrrolate (GLY) delivered via iontophoresis in promoting bowel movement in persons with chronic SCI. This will be quantified by the presence and strength of biological responses (changes in bowel sounds, heart rate and airway resistance and bowel movement occurrence).
1 secondary outcome
Safety of Study Medication (quantified through monitoring of side effects during study visits and through patient self report as measured by the Treatment Satisfaction Questionnaire)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Korsten, MD principal investigator
James J. Peters VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neostigmine and Glycopyrrolate in people with Spinal Cord Injury and Neurogenic Bowel, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Responses to Study Drugs (quantified by the presence and strength of biological responses (changes in bowel sounds, heart rate and airway resistance and bowel movement occurrence) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.