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NCT00914056 · ClinicalTrials.gov registry record · NA
A Study of Controlled Lactulose Withdrawal
A NA study, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT00914056: Completed NA study, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
NCT00914056 is a NA study that has completed, run by Hunter Holmes Mcguire Veteran Affairs Medical Center. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00914056, a NA study, has completed, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
After resolution of the initial episode of hepatic encephalopathy (HE), lactulose is routinely continued indefinitely as maintenance therapy. Although widely used for this indication, lactulose has never been shown in randomized, controlled trials to be effective for preventing exacerbations of HE. Indeed, lactulose was found to be ineffective at preventing HE when administered prophylactically to patients undergoing portosystemic shunt insertion. While some patients may be lactulose dependent following an initial episode of HE, it is likely that most could have their lactulose discontinued with no adverse consequences. This goal is worth pursuing because lactulose is not innocuous. It has an unpleasant taste, and it routinely produces gastrointestinal symptoms, including bloating, gas and diarrhea. In high doses it can cause incontinence, dehydration and electrolyte derangements. Patients universally dislike taking lactulose and often are noncompliant with treatment. A recent trial showed that patients on lactulose had a substantial risk of hospital admissions due to lactulose-related complications and treatment non-compliance.
Interventions
- DRUG lactulose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-05 |
| Phase | NA |
What the finished NCT00914056 record still lists
NCT00914056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which lactulose is the first listed.
NCT00914056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00914056 about?
NCT00914056 is a clinical study titled "A Study of Controlled Lactulose Withdrawal". After resolution of the initial episode of hepatic encephalopathy (HE), lactulose is routinely continued indefinitely as maintenance therapy. Although widely used for this indication, lactulose has never been shown in randomized, controlled trials to be effective for preventing exacerbations of HE. ...
What is the current status of trial NCT00914056?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2008-09. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00914056?
The interventions under investigation include: lactulose (DRUG).
Who is sponsoring clinical trial NCT00914056?
This trial is sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00914056's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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