drugset / Trial / NCT02163434
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
Phase 2
Completed
31 enrolled
State University of New York at Buffalo
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2014-06
- Primary completion
- 2019-10
- Completion
- 2019-11
Publications
- Background Guttuso T Jr, Robinson LK, Amankwah KS. Gabapentin use in hyperemesis gravidarum: a pilot study. Early Hum Dev. 2010 Jan;86(1):65-6. doi: 10.1016/j.earlhumdev.2009.11.003. Epub 2009 Dec 16.
- Background Holmes LB, Hernandez-Diaz S. Newer anticonvulsants: lamotrigine, topiramate and gabapentin. Birth Defects Res A Clin Mol Teratol. 2012 Aug;94(8):599-606. doi: 10.1002/bdra.23028. Epub 2012 Jun 22.
- Background Guttuso T Jr. Gabapentin's anti-nausea and anti-emetic effects: a review. Exp Brain Res. 2014 Aug;232(8):2535-9. doi: 10.1007/s00221-014-3905-1. Epub 2014 Mar 26.
- Guttuso T Jr, Messing S, Tu X, Mullin P, Shepherd R, Strittmatter C, Saha S, Thornburg LL. Effect of gabapentin on hyperemesis gravidarum: a double-blind, randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100273. doi: 10.1016/j.ajogmf.2020.100273. Epub 2020 Oct 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 1800 mg | Oral |
| Subject | Gabapentin | Small molecule | 2400 mg | Oral |
| Subject | Metoclopramide | Small molecule | 45 mg | Oral |
| Subject | Metoclopramide | Small molecule | 60 mg | Oral |