Spinal Cord InjuriesPhase 1TWBCNCT04671030
Use of a Prokinetic Agent as an Adjunct to Thrice Weekly Bowel Care After SCI
A Phase 1 study testing Neostigmine and Glycopyrrolate and Iontophoresis in people with Spinal Cord Injuries and Constipation, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Constipation, Neurogenic Bowel
- What is being tested?
- Neostigmine and Glycopyrrolate and Iontophoresis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2018to 3 Jun 2021
- Phase
- 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
- Healthy volunteers accepted
- Adult, Older adult
- Inclusion Criteria:
- Spinal Cord Injury:
- Level of injury C1 to S4
- Duration of injury over 1 year
- Excess time for bowel evacuation (over 60 minutes per bowel training session).
- Exclusion Criteria:
- Previous Adverse Reaction or Hypersensitivity to Electrical Stimulation
- Do not require additional bowel care or have "normal bowel function"
- Known sensitivity to Neostigmine and Glycopyrrolate
- Blockage in Bowel or Bladder
- Myocardial Infarction in the past 6months
- Blood Pressure over 160 over 100 mg Hg with being on 3 or more different classes of antihypertensive medications
- Organ Damage (heart and kidney) and/or TIA, CVA as a result of hypertension
- Known past history of coronary artery disease, chronic heart failure, bradyarrythmia
- Slow Heart Rate (under 45 bpm)
- Active respiratory diseases
- Known history of asthma during lifetime
- Recent (within 3 months) respiratory infections
- Adrenal Insufficiency
- Pregnancy or potential for pregnancy
- Lactating/nursing females
- Use of any antibiotics in past 7 days
- Use of medications known to affect respiratory system
- 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: Effects of the Addition of a Prokinetic Agent to Thrice Weekly Bowel Care in Individuals With 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 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.
Read the detailed description
Part 1: IV Screening Twenty subjects with chronic SCI (>1 year) and difficulty with evacuation (DWE) managed by a regular, thrice weekly bowel care (BC) routines will be recruited for study participation. In order to determine eligibility for the study, the subject will have to undergo an IV screening to test whether or not they are responsive to the drug treatment (neostigmine-glycopyrrolate). Subjects will receive the following dose: 0.03mg/kg neostigmine (NEO) and 0.006mg/kg glycopyrrolate (GLY). If the subject responds (bowel movement) to the IV treatment, they will be allowed to continue on to part 2 of the study. If patient does not have a successful bowel movement, then they will be considered a non-responder and study participation will be discontinued. Study procedures can be found in table below.
Part 2: Baseline and Iontophoresis Screening Once eligibility has been determined, and subject consent has been obtained, each subject will undergo 1 week of baseline observation. An abdominal x-ray (KUB) will be performed, the SCI Bowel Survey and Treatment Satisfaction Questionnaire (TSQM) will be administered, and the subject's weight determined. Each subject will continue with regular bowel care and after 1 week, all of the baseline measurements (KUB, weight and surveys) will be repeated. This will be followed by an additional screening visit during which we will concomitantly administer transcutaneous NEO and GLY via iontophoresis (ION). Subjects will receive the following dose: 0.07mg/kg NEO and 0.014mg/kg GLY. This visit will be scheduled on a BC day. All procedures will take place in the "Blue Room" located in the SCI ward. As part of the setup, subjects will be instrumented with blood pressure cuff; intravenous access will be obtained at a peripheral vein (if one is not available), as a precautionary measure, since the drug will be administered via an Iontophoresis transdermal patch. Heart rate will be continuously monitored throughout the procedure through finger oximetry. Symptoms will be assessed every 5 minutes for 60 minutes. Impulse Oscillometry system (IOS) will be used to measure the effect of the medication on airway obstruction. If the subject has a positive response (bowel movement within 60 minutes of drug administration) he/she will be eligible to continue to the third study phase. If the subject does not respond, the subject will be considered a non-responder and study participation will be discontinued. We expect that about 1/3rd of the subjects will be non-responders, or will be lost to attrition; therefore, we are prepared to over-recruit by 5 subjects in order to ensure that at least 15 subjects will be eligible to complete the second part of the study.
The study will be stopped once the patient experiences a bowel movement within 30 minutes of administering ION NEO because the protocol objective will have been achieved. If the patient should experience cardiopulmonary side effects when receiving the ION NEO that are not effectively reversed by the ION GLY, the study will be stopped. In addition, the study investigators reserve the right to stop the study should they have any other safety concerns.
Part 3: 2 Week Treatment Each subject will be assessed for their perception of their current BC routine using the Treatment Satisfaction Questionnaire for Medication (TSQM-Appendix 1), and their bowel habits using the bowel survey (Appendix 2).The subject will then be asked to continue with their normal BC routine for two weeks, with the exception that NEO and GLY will be administered at the beginning of each BC session as an adjunct to each subject's normal routine. Subjects will be asked to come to the JJPVAMC for each BC session. Each BC session will be documented by a study team member including the time needed to complete BC, methods used (i.e. number of enemas used, oral laxatives, suppositories, digital stimulation, abdominal massage) and the quality and completeness of the bowel movement. Heart rate, oxygenation and blood pressure will be monitored continuously. Subjects will be weighed at baseline, once after each week of treatment and once at the post treatment follow-up visit. After two weeks of treatment, each subject will undergo a final KUB and be reassessed for their perception of the BC routine for the past two weeks using the TSQM and their bowel habits (bowel survey).
*During the treatment period (part 3), monitoring will take place for the first hour after administration of study medications. However, bowel care will continue for as long as is clinically indicated. Additional techniques for bowel care (i.e. enema, suppository, digital stimulation, etc.) will be used in coordination with SCI nurses to promote bowel evacuation for subjects who do not respond.
**An IV line will be inserted during all study visits. Study medication will be administered intravenously during Part 1 only. An IV line will be available however through all sessions involving study medication for safety purposes in the case that an antidote needs to be administered
- Conditions
- Spinal Cord Injuries, Constipation, Neurogenic Bowel
- Being tested
- Neostigmine and Glycopyrrolate, Iontophoresis
- Keywords
- Neostigmine, Glycopyrrolate, Transdermal, Intravenous, Constipation, Bowel care, Neurogenic bowel
- Medical subject headings
- Spinal Cord Injuries, Constipation, Neurogenic Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine and GlycopyrrolateDrug
Intravenous followed by transdermal administration of the two drug combination.
IontophoresisDevice
Also called I-Box
Application of direct current to skin using an FDA-approved device
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Subjects are screened by criteria, intravenous and transdermal iontophoresis then undergo the study during which they will be administered the placebo alternating with real drug without being aware of which is being given. Receives: Drug: Neostigmine and Glycopyrrolate; Device: Iontophoresis |
| Placebo group | Placebo comparator | Placebo will be given without the subject being aware of the time in advance. Receives: Device: Iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first bowel evacuation
Measured from completion of adminstration to first bowel evacuation
Measured: within 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Jan 2018
- Primary completion22 Jun 2018
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Single group interventional study with brief crossover of subjects into the placebo group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dr. Mark Korsten, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671030
- Sponsor's protocol ID
- KOR-12-35
- Acronym
- TWBC
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2020
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Addition of a Prokinetic Agent to Thrice Weekly Bowel Care in Individuals With SCI
- ClinicalTrials.gov ID
- NCT04671030
- Acronym / sponsor ID
- TWBC / KOR-12-35
- Conditions
- Spinal Cord Injuries, Constipation, Neurogenic Bowel
- Keywords
- Neostigmine, Glycopyrrolate, Transdermal, Intravenous, Constipation, Bowel care, Neurogenic bowel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- 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.
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.
Detailed description
Part 1: IV Screening Twenty subjects with chronic SCI (>1 year) and difficulty with evacuation (DWE) managed by a regular, thrice weekly bowel care (BC) routines will be recruited for study participation. In order to determine eligibility for the study, the subject will have to undergo an IV screening to test whether or not they are responsive to the drug treatment (neostigmine-glycopyrrolate). Subjects will receive the following dose: 0.03mg/kg neostigmine (NEO) and 0.006mg/kg glycopyrrolate (GLY). If the subject responds (bowel movement) to the IV treatment, they will be allowed to continue on to part 2 of the study. If patient does not have a successful bowel movement, then they will be considered a non-responder and study participation will be discontinued. Study procedures can be found in table below.
Part 2: Baseline and Iontophoresis Screening Once eligibility has been determined, and subject consent has been obtained, each subject will undergo 1 week of baseline observation. An abdominal x-ray (KUB) will be performed, the SCI Bowel Survey and Treatment Satisfaction Questionnaire (TSQM) will be administered, and the subject's weight determined. Each subject will continue with regular bowel care and after 1 week, all of the baseline measurements (KUB, weight and surveys) will be repeated. This will be followed by an additional screening visit during which we will concomitantly administer transcutaneous NEO and GLY via iontophoresis (ION). Subjects will receive the following dose: 0.07mg/kg NEO and 0.014mg/kg GLY. This visit will be scheduled on a BC day. All procedures will take place in the "Blue Room" located in the SCI ward. As part of the setup, subjects will be instrumented with blood pressure cuff; intravenous access will be obtained at a peripheral vein (if one is not available), as a precautionary measure, since the drug will be administered via an Iontophoresis transdermal patch. Heart rate will be continuously monitored throughout the procedure through finger oximetry. Symptoms will be assessed every 5 minutes for 60 minutes. Impulse Oscillometry system (IOS) will be used to measure the effect of the medication on airway obstruction. If the subject has a positive response (bowel movement within 60 minutes of drug administration) he/she will be eligible to continue to the third study phase. If the subject does not respond, the subject will be considered a non-responder and study participation will be discontinued. We expect that about 1/3rd of the subjects will be non-responders, or will be lost to attrition; therefore, we are prepared to over-recruit by 5 subjects in order to ensure that at least 15 subjects will be eligible to complete the second part of the study.
The study will be stopped once the patient experiences a bowel movement within 30 minutes of administering ION NEO because the protocol objective will have been achieved. If the patient should experience cardiopulmonary side effects when receiving the ION NEO that are not effectively reversed by the ION GLY, the study will be stopped. In addition, the study investigators reserve the right to stop the study should they have any other safety concerns.
Part 3: 2 Week Treatment Each subject will be assessed for their perception of their current BC routine using the Treatment Satisfaction Questionnaire for Medication (TSQM-Appendix 1), and their bowel habits using the bowel survey (Appendix 2).The subject will then be asked to continue with their normal BC routine for two weeks, with the exception that NEO and GLY will be administered at the beginning of each BC session as an adjunct to each subject's normal routine. Subjects will be asked to come to the JJPVAMC for each BC session. Each BC session will be documented by a study team member including the time needed to complete BC, methods used (i.e. number of enemas used, oral laxatives, suppositories, digital stimulation, abdominal massage) and the quality and completeness of the bowel movement. Heart rate, oxygenation and blood pressure will be monitored continuously. Subjects will be weighed at baseline, once after each week of treatment and once at the post treatment follow-up visit. After two weeks of treatment, each subject will undergo a final KUB and be reassessed for their perception of the BC routine for the past two weeks using the TSQM and their bowel habits (bowel survey).
*During the treatment period (part 3), monitoring will take place for the first hour after administration of study medications. However, bowel care will continue for as long as is clinically indicated. Additional techniques for bowel care (i.e. enema, suppository, digital stimulation, etc.) will be used in coordination with SCI nurses to promote bowel evacuation for subjects who do not respond.
**An IV line will be inserted during all study visits. Study medication will be administered intravenously during Part 1 only. An IV line will be available however through all sessions involving study medication for safety purposes in the case that an antidote needs to be administered
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single group interventional study with brief crossover of subjects into the placebo group
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Neostigmine and Glycopyrrolate, Device: IontophoresisSubjects are screened by criteria, intravenous and transdermal iontophoresis then undergo the study during which they will be administered the placebo alternating with real drug without being aware of which is being given. |
| Placebo group | Placebo comparator | Device: IontophoresisPlacebo will be given without the subject being aware of the time in advance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 GlycopyrrolateIntravenous followed by transdermal administration of the two drug combination. | Drug | Treatment group |
| IontophoresisAlso: I-BoxApplication of direct current to skin using an FDA-approved device | Device | Placebo group, Treatment group |
Primary outcome
Time to first bowel evacuation
Time frame: within 1 hour
Measured from completion of adminstration to first bowel evacuation
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 30 Dec 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neostigmine and Glycopyrrolate and Iontophoresis in people with Spinal Cord Injuries and Constipation, 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?
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 30 Dec 2021. 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Time to first bowel evacuation (time frame: within 1 hour). 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 30 Dec 2021.