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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: Completed Phase 2 study, sponsored by US Department of Veterans Affairs.
NCT00855283 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00855283 record still lists
NCT00855283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which IN NEO is the first listed.
NCT00855283 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00855283's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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