Status:
COMPLETED
Intranasal Administration of a Prokinetic for Bowel Evacuation in Persons With SCI
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
SCI
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
Brief Summary
DWE (difficulty with evacuation) is a common and an important quality of life issue after spinal cord injury. Not only is the management DWE time-consuming and unpleasant, but the results are often su...
Detailed Description
We have been studying the effects of spinal cord injury on the bowel for over ten years. Our data suggests that one of the fundamental consequences of spinal cord injury is a slowing of intestinal per...
Eligibility Criteria
Inclusion
- Incomplete or complete SCI
- Tetraplegia or paraplegia
- Males or females
- Age 18 (no upper age limit)
- Excess time for bowel evacuation (\> 60 minutes per bowel training session)
Exclusion
- Persons with SCI who do not require do not require additional bowel care or have "normal bowel function"
- Known hypersensitivity to neostigmine or glycopyrrolate
- History of mechanical obstruction of the intestine or urinary tract.
- Myocardial infarction within less than 6 months of trial.
- Hemodynamic instability
- Potential for pregnancy. (Women who are sexually active and of childbearing potential (i.e. not surgically sterile or at least 2 year postmenopausal) must be have a negative serum pregnancy test and to have utilized one of the following methods of contraception prior to screening: barrier (condom, diaphragm with spermicide) intrauterine device, or tubal ligation beginning at least 30 days prior; hormonal (oral, injectable, transdermal, or implanted) beginning at least 3 months prior; or vasectomized partner for at least the prior 6 months. Subjects must agree to maintain these contraceptive methods through the completion of the study.)
- Lactating/nursing females
- Patients who develop significant bradycardia (HR\<42 bpm) or other significant anticholinergic symptoms (e.g., severe cramps, dry mouth, etc.) any time during the study will be discontinued.
- Concurrent participation in other clinical trials (within 30 days).
- Use of concurrent medications that affect cardiac output (e.g. tricyclics, beta blockers, etc.)
- Fluctuating use of concurrent medications (should be stable for 3-4 weeks before and no changes anticipated throughout the study).
- History of reduced cardiac output (via history and ECG) in addition to myocardial infarction and hemodynamic instability.
- Concurrent history of peripheral vascular disease, kidney disease, etc.
- Asthma or other broncho-constrictive disorders.
- Hemoglobin level \< 12 g/dL
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00855283
Start Date
September 1 2012
End Date
June 1 2013
Last Update
July 24 2013
Active Locations (1)
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1
VA Medical Center, Bronx
The Bronx, New York, United States, 10468