Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02052440 · ClinicalTrials.gov registry record · Phase 3
Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
A Phase 3 study, sponsored by Denver Health and Hospital Authority.
- Terminated
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
NCT02052440 is a Phase 3 study that was terminated before completion, run by Denver Health and Hospital Authority. The registered enrollment target is 102 participants.
The verdict
NCT02052440, a Phase 3 study, was terminated before completion, sponsored by Denver Health and Hospital Authority.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
Study Summary
Adult medical/surgical inpatient hospital care is more difficult and more expensive when complicated by alcohol dependency (AD), especially for patients who develop alcohol withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS ≥ 7) has important clinical implications and requires pharmacological treatment. At present, there are no safe and effective options for preventing AWS in at-risk inpatients. Baclofen is a GABA-B receptor agonist that has been used in the alleviation of spasticity in patients with multiple sclerosis since the 1970s. Baclofen has shown promise in the management of alcohol dependency in preclinical and clinical studies. We propose to examine baclofen in the prevention/amelioration of AWS in adult medical inpatients. The investigators hypothesize that Baclofen, as compared to placebo, will significantly reduce the number of adult inpatients with AD who will develop moderate/severe AWS (SEWS ≥ 7) when assessed at 72 hours after enrollment. Further the investigators hypothesize that Baclofen, as compared to placebo, will significantly reduce the need for symptom-triggered benzodiazepine administration during the 72 hours of hospitalization. These hypotheses will be tested in adult inpatients who are determined to be at risk for alcohol withdrawal and are subsequently placed on the SEWS monitoring and treatment protocol. These patients will be randomized to baclofen 10mg three times daily vs placebo.
Interventions
- DRUG Placebo
- DRUG Baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2014-03-15 |
| Est. Completion | 2017-01-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02052440
The ClinicalTrials.gov registry entry for NCT02052440 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02052440 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02052440 about?
NCT02052440 is a clinical study titled "Preventing Alcohol Withdrawal Syndrome With Oral Baclofen". Adult medical/surgical inpatient hospital care is more difficult and more expensive when complicated by alcohol dependency (AD), especially for patients who develop alcohol withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol Withdrawal Scale (SEWS) is tool used to...
What is the current status of trial NCT02052440?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2014-03-15. Estimated completion is 2017-01-01.
What interventions are being tested in trial NCT02052440?
The interventions under investigation include: Placebo (DRUG), Baclofen (DRUG).
Who is sponsoring clinical trial NCT02052440?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.