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NCT00855283 · ClinicalTrials.gov registry record · Phase 2
Intranasal Administration of a Prokinetic for Bowel Evacuation in Persons With SCI
A Phase 2 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00855283 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 20 participants.
The verdict
NCT00855283, a Phase 2 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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 suboptimal in terms of complications such as incontinence and impaction. Bowel care regimens after spinal cord injury have not changed in any significant fashion in many years. The usual strategies for attaining bowel evacuation involve dietary manipulation (e.g., high fiber diets and hydration), thrice weekly laxative administration (senna and cascara) and thrice weekly anorectal instillation of cathartics (enemas and suppositories). Bowel care can be quite time consuming (greater than 2 hours in many instances) and may also require extensive nursing care. Finally, incomplete evacuation could contribute to fecal incontinence that has significant morbidity in these patients. In preliminary studies performed at the JJPVAMC, IV, IM, and subcutaneous injection of neostigmine combined with glycopyrrolate were demonstrated to be highly effective to promote bowel evacuation in the SCI population. In an effort to provide a more realistic administration of this procedure, we propose to test the intranasal spray injection of neostigmine and glycopyrrolate for safety and efficacy.
Interventions
- DRUG IN NEO
- DRUG IN NEO + IN Glycopyrrolate
- DRUG IV Visit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00855283
The ClinicalTrials.gov registry entry for NCT00855283 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which IN NEO is the first listed.
NCT00855283 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00855283 about?
NCT00855283 is a clinical study titled "Intranasal Administration of a Prokinetic for Bowel Evacuation in Persons With SCI". 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 suboptimal in terms of complications such as incontinence and impaction. Bowel care regimens after spi...
What is the current status of trial NCT00855283?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2012-09. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00855283?
The interventions under investigation include: IN NEO (DRUG), IN NEO + IN Glycopyrrolate (DRUG), IV Visit (DRUG).
Who is sponsoring clinical trial NCT00855283?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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