At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
Gabapentin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
In Brief
A Phase 2 clinical trial evaluating Gabapentin and Metoclopramide for Hyperemesis Gravidarum. Completed, enrolled 31 participants across 2 sites.
Detailed Summary
The investigators will compare the effectiveness of gabapentin to metoclopramide for 1 week among 60 women with hyperemesis gravidarum (HG) in this randomized, double-blinded trial. After completion of the 1-week double-blind phase, subjects will be offered open-label gabapentin with rescue metoclopramide until their symptoms no longer require treatment. Enrollment will occur at the University's at Buffalo, of Rochester and of Wisconsin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperemesis Gravidarum
CountriesUnited States
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedJun 2014
Primary CompletionOct 2019
Study CompletionNov 2019
TodayJul 2026
First PostedJun 13, 2014
Enrollment StartJun 1, 2014
Primary CompletionOct 1, 2019
Study CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.1 years ago
Interventions
Gabapentindrug
Metoclopramidedrug