TWBC
Effects of the Addition of a Prokinetic Agent to Thrice Weekly Bowel Care in Individuals With SCI
Sponsor study identifier
interventional
6
1 country
1
Study Start
January 15, 2018
Actual (reported)Primary Completion
June 22, 2018
Actual (reported)Study Completion
June 3, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 3, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2018
Actual (reported)June 22, 2018
Actual (reported)December 10, 2020
Actual (reported)December 17, 2020
Actual (reported)June 3, 2021
Actual (reported)Time to first bowel evacuation
Measured from completion of adminstration to first bowel evacuation
within 1 hour
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.
Placebo will be given without the subject being aware of the time in advance.
Intravenous followed by transdermal administration of the two drug combination.
Application of direct current to skin using an FDA-approved device
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Neostigmine and Glycopyrrolate
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordJames J Peters VA Medical Center
The Bronx, New York, 10468, United States
6 participants (actual enrollment reported by the registry).
First Submitted
December 10, 2020
First Posted
December 17, 2020
Study Start
Neostigmine and Glycopyrrolate by Iontophoresis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
January 15, 2018
Actual (reported)Primary Completion
June 22, 2018
Actual (reported)Study Completion
June 3, 2021
Actual (reported)Last Updated
December 30, 2021
Record last verified: 2021-12
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Source: ClinicalTrials.gov.
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