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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 is a NA study that has completed, run by Hunter Holmes Mcguire Veteran Affairs Medical Center. The registered enrollment target is 7 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00914056
The ClinicalTrials.gov registry entry for NCT00914056 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lactulose is the first listed.
NCT00914056 reports 0 study locations.
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.
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