Spinal Cord InjuryPhase 1NCT02370433
Use of Prokinetics During Inpatient Bowel Care for SCI Patients
A Phase 1 study testing Intravenous Neostigmine and Glycopyrrolate and Transdermal 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?
- Intravenous Neostigmine and Glycopyrrolate and Transdermal Neostigmine and Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years
- Spinal Cord Injury (SCI):
- greater than 1 year duration
- excess time for bowel evacuation (> 60minutes per session)
Who cannot join
- 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 and/or Bladder
- Myocardial Infarction in the past 6months
- Blood Pressure ≥160/100 mmHg with/without being on 3 or more different classes of antihypertensive medications
Show all 18Show fewer
- Organ Damage (heart \& kidney) and/or transient ischemic attack (TIA)- cerebrovascular accident (CVA) as a result of hypertension
- Known past history of coronary artery disease, chronic heart failure, bradyarrythmia
- Slow Heart Rate (<45bpm)
- Active respiratory diseases
- Known history of asthma during lifetime
- Recent (within 3months) respiratory infections
- Adrenal Insufficiency
- Pregnancy or potential for pregnancy
- Lactating/nursing females
- Use of any antibiotics in past 7days
- Use of medications known to affect respiratory system
- Concurrent participation in other clinical trials (within 30days)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
James J. Peters VA Medical Center
The Bronx, New York, 10468
Brian Lyons, 718-584-9000 ext. 3128, brian.lyons@va.gov
Joshua Hobson, 718-584-9000 ext. 3129, joshua.hobson@va.gov
About this study
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 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 study, we would like to test the applicability of this medication to bowel care routines.
The investigators believe that the addition of this medication to the beginning of regular bowel regiments will significantly decrease the time and effort needed to complete BC, thus improving patient perception of their BC routines and quality of life. SCI individuals followed by the James J Peters VA Medical Center (JJPVAMC) SCI Medical Service are admitted on a routine basis for inpatient respite care, therapy, and/or annual physicals. Such inpatient stays typically range in duration from 1 week to 3 weeks, during which the patient undergo BC routines assisted by the inpatient care team. BC routines are typically performed every other day, or thrice weekly (Monday, Wednesday, Friday) in "Blue Rooms" located on the inpatient SCI wards (IE and ID). The bowel care routine, including duration of procedure, use of assistive medications or devices, and completeness of bowel care are documented in the patients' electronic medical chart (CPRS) by care providers. The investigators propose to perform the described protocol in individuals who have been admitted to the hospital for routine care and are otherwise healthy. In doing so, the investigators can ensure that patients are vigilantly monitored during each BC session, and that any changes in BC pattern are accurately observed and documented. Furthermore, by performing these procedures on an inpatient basis, study investigators can ensure the consistency of care and daily routine, allowing for better control of study conditions.
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 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). 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.
Part 2: Baseline and Dose Titration Once eligibility has been determined, and subject consent has been obtained, each subject will undergo 1 week of baseline observation after admission. 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 as an inpatient, and after 1 week, all of the baseline measurements (KUB, weight and surveys) will be repeated. This will be followed by a 2 visit- dose titration study of concomitantly administered, transcutaneous neostigmine methylsulfate (NEO) and glycopyrrolate (GLY). Each visit will be scheduled on a BC day. All procedures will take place in the "Blue Room" located in the SCI inpatient ward. Subjects will be prone throughout the duration of the study, in a stretcher routinely used during bowel care. 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 the first 30 minutes, and then at 1 hour post drug administration. Once the subject has a positive response to one of the two doses, or the higher dose has been performed, the dose titration will be stopped. 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 to either dose, 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 on the lower doses 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 during their inpatient stay, 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. 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).
- Conditions
- Spinal Cord Injury, Neurogenic Bowel
- Being tested
- Intravenous Neostigmine and Glycopyrrolate, Transdermal Neostigmine and Glycopyrrolate
- Keywords
- Spinal Cord Injury, Neurogenic Bowel, Bowel Evacuation
- 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.
Intravenous Neostigmine and GlycopyrrolateDrug
Transdermal Neostigmine and GlycopyrrolateDrug
| Study group | Role | What they receive |
|---|---|---|
| Bowel Evacuation via IV | Experimental | The study design will consist of an intravenous (IV) screening visit to determine each individual's response to neostigmine and glycopyrrolate (NG). Receives: Drug: Intravenous Neostigmine and Glycopyrrolate |
| Bowel Evacuation Titration | Experimental | This design will consist of a dose titration for those subjects who respond positively to IV. These subjects will receive either a low dose and/or a high dose of NG via iontophoresis to determine their responsiveness. Receives: Drug: Transdermal Neostigmine and Glycopyrrolate |
| Bowel Evacuation Iontophoresis | Experimental | This design will consist of the incorporation of iontophoresis administration into clinical bowel care. The subject will receive the exact dose they responded to during the titration 3x per week for 2weeks. Receives: Drug: Transdermal Neostigmine and Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological Response to Study Medication (Changes in BC habits (time to complete BC, reductions/ increases in secondary methods (enemas, suppositories, oral supplements) needed to complete BC will be assessed)
We aim to evaluate the effect of treatment with NG through Iontophoresis during routine bowel care (BC) during inpatient visits. Changes in BC habits (time to complete BC, reductions/ increases in secondary methods (enemas, suppositories, oral supplements) needed to complete BC will be assessed
Measured: 24months
Secondary outcomes (2)
Effect of Medication on Impaction (changes in fecal impaction and constipation by documenting weekly weight and pre to post treatment plain abdominal x-ray)
We aim to To evaluate changes in fecal impaction and constipation by documenting weekly weight and pre to post treatment plain abdominal x-ray
Measured: 24months
Subjective Feedback from Inpatients (Treatment Satisfaction Questionnaire for Medication (TSQM)
We aim To compare patient perception of the proposed treatment using the Treatment Satisfaction Questionnaire for Medication (TSQM) before and after the inpatient treatment period.
Measured: 24months
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 startDec 2012
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
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
- NCT02370433
- Sponsor's protocol ID
- KOR-12-035
- Status last verified
- Aug 2017
- First submitted
- 18 Feb 2015
- Last updated
- 29 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Prokinetics During Inpatient Bowel Care for SCI Patients
- ClinicalTrials.gov ID
- NCT02370433
- Acronym / sponsor ID
- KOR-12-035
- Conditions
- Spinal Cord Injury, Neurogenic Bowel
- Keywords
- Spinal Cord Injury, Neurogenic Bowel, Bowel Evacuation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- Dec 2012
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- 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 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 study, we would like to test the applicability of this medication to bowel care routines.
The investigators believe that the addition of this medication to the beginning of regular bowel regiments will significantly decrease the time and effort needed to complete BC, thus improving patient perception of their BC routines and quality of life. SCI individuals followed by the James J Peters VA Medical Center (JJPVAMC) SCI Medical Service are admitted on a routine basis for inpatient respite care, therapy, and/or annual physicals. Such inpatient stays typically range in duration from 1 week to 3 weeks, during which the patient undergo BC routines assisted by the inpatient care team. BC routines are typically performed every other day, or thrice weekly (Monday, Wednesday, Friday) in "Blue Rooms" located on the inpatient SCI wards (IE and ID). The bowel care routine, including duration of procedure, use of assistive medications or devices, and completeness of bowel care are documented in the patients' electronic medical chart (CPRS) by care providers. The investigators propose to perform the described protocol in individuals who have been admitted to the hospital for routine care and are otherwise healthy. In doing so, the investigators can ensure that patients are vigilantly monitored during each BC session, and that any changes in BC pattern are accurately observed and documented. Furthermore, by performing these procedures on an inpatient basis, study investigators can ensure the consistency of care and daily routine, allowing for better control of study conditions.
Detailed description
Part 1: IV Screening Twenty subjects with chronic SCI (>1 year) and difficulty with evacuation (DWE) managed by a regular, thrice weekly 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). 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.
Part 2: Baseline and Dose Titration Once eligibility has been determined, and subject consent has been obtained, each subject will undergo 1 week of baseline observation after admission. 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 as an inpatient, and after 1 week, all of the baseline measurements (KUB, weight and surveys) will be repeated. This will be followed by a 2 visit- dose titration study of concomitantly administered, transcutaneous neostigmine methylsulfate (NEO) and glycopyrrolate (GLY). Each visit will be scheduled on a BC day. All procedures will take place in the "Blue Room" located in the SCI inpatient ward. Subjects will be prone throughout the duration of the study, in a stretcher routinely used during bowel care. 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 the first 30 minutes, and then at 1 hour post drug administration. Once the subject has a positive response to one of the two doses, or the higher dose has been performed, the dose titration will be stopped. 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 to either dose, 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 on the lower doses 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 during their inpatient stay, 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. 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bowel Evacuation via IV | Experimental | Drug: Intravenous Neostigmine and GlycopyrrolateThe study design will consist of an intravenous (IV) screening visit to determine each individual's response to neostigmine and glycopyrrolate (NG). |
| Bowel Evacuation Titration | Experimental | Drug: Transdermal Neostigmine and GlycopyrrolateThis design will consist of a dose titration for those subjects who respond positively to IV. These subjects will receive either a low dose and/or a high dose of NG via iontophoresis to determine their responsiveness. |
| Bowel Evacuation Iontophoresis | Experimental | Drug: Transdermal Neostigmine and GlycopyrrolateThis design will consist of the incorporation of iontophoresis administration into clinical bowel care. The subject will receive the exact dose they responded to during the titration 3x per week for 2weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-75 years
- Spinal Cord Injury (SCI):
- greater than 1 year duration
- excess time for bowel evacuation (> 60minutes per session)
Key exclusion criteria (18 listed)
- 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 and/or Bladder
- Myocardial Infarction in the past 6months
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 |
|---|---|---|
| Intravenous Neostigmine and Glycopyrrolate | Drug | Bowel Evacuation via IV |
| Transdermal Neostigmine and Glycopyrrolate | Drug | Bowel Evacuation Iontophoresis, Bowel Evacuation Titration |
Primary outcome
Biological Response to Study Medication (Changes in BC habits (time to complete BC, reductions/ increases in secondary methods (enemas, suppositories, oral supplements) needed to complete BC will be assessed)
Time frame: 24months
We aim to evaluate the effect of treatment with NG through Iontophoresis during routine bowel care (BC) during inpatient visits. Changes in BC habits (time to complete BC, reductions/ increases in secondary methods (enemas, suppositories, oral supplements) needed to complete BC will be assessed
2 secondary outcomes
Effect of Medication on Impaction (changes in fecal impaction and constipation by documenting weekly weight and pre to post treatment plain abdominal x-ray)
Time frame: 24months
Subjective Feedback from Inpatients (Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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.
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 Intravenous Neostigmine and Glycopyrrolate and Transdermal 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 4 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: status not confirmed, as of the sponsor's last update on 29 Aug 2017. 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark A Korsten, MD (718-584-9000 ext. 6753, mark.korsten@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Response to Study Medication (Changes in BC habits (time to complete BC, reductions/ increases in secondary methods (enemas, suppositories, oral supplements) needed to complete BC will be assessed) (time frame: 24months). 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 29 Aug 2017.