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Clinical trial

NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI

ID
Name
H22-00878
Description
This project aims to evaluate the safety and efficacy of using a short-acting drug to reduce the maximal blood pressure during dangerous blood pressure spikes that happen during bowel care in individuals with spinal cord injury. the investigators will monitor the physiological effects of this drug during at-home bowel care to best understand the drug's effects in typical use.
Trial arms
Trial start
2024-09-01
Estimated PCD
2025-02-01
Trial end
2025-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Glyceryl Trinitrate Only Product in Oromucosal Dose Form
Glyceryl trinitrate will be administered via sublingual spray.
Arms:
Glyceryl trinitrate sublingual spray
Other names:
GTN
Placebo sublingual spray
A placebo sublingual spray will be administered.
Arms:
Placebo sublingual spray
Other names:
Placebo spray
Size
26
Primary endpoint
Blood pressure change during bowel care
Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Eligibility criteria
Inclusion Criteria: * participants must have had a traumatic spinal cord injury at least one year ago * regular bowel care routine * can communicate in English Exclusion Criteria: * cauda equina or conus lesions * currently use ventilator * colostomy, or do not perform regular bowel care * skin breakdown (pressure sores) * cannot communicate in English * under 19 years old * possibly or certainly pregnant * medical/psychiatric condition or substance abuse that is likely to affect ability to complete study * currently using medications containing PDE-5 inhibitors * currently using medications containing GTN * allergy to GTN
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ESTIMATED'}}
Updated at
2024-04-17

1 organization

1 product

2 indications

Organization
Simon Fraser University
Product
Glyceryl Trinitrate
Indication
Spinal Cord Injuries
Indication
Autonomic Dysreflexia