Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
This study is currently recruiting participants.
Verified August 2015 by Thomas Guttuso, University at Buffalo
Sponsor:
University at Buffalo
ClinicalTrials.gov Identifier:
NCT02163434
First Posted: June 13, 2014
Last Update Posted: August 4, 2015
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Thomas Guttuso, University at Buffalo
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Purpose
The investigators will compare the effectiveness of gabapentin to metoclopramide for 1-2 weeks among 80 women with hyperemesis gravidarum (HG) in this randomized, double-blinded trial. After completion of the 2-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 at Buffalo and the University of Rochester.
| Condition | Intervention | Phase |
|---|---|---|
| Hyperemesis Gravidarum | Drug: Gabapentin Drug: Metoclopramide | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
| Official Title: | Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum |
Resource links provided by NLM:
Drug Information available for:
Metoclopramide
Metoclopramide hydrochloride
Gabapentin
Gabapentin enacarbil
U.S. FDA Resources
Further study details as provided by Thomas Guttuso, University at Buffalo:
Primary Outcome Measures:
- Mean percent change from Baseline to the Study Endpoint in daily Motherisk-PUQE scores (pregnancy-unique quantification of emesis and nausea scale). [ Time Frame: 2 weeks ]This study will utilize a flexible study endpoint in order to focus assessments of the outcome measures in the outpatient setting and before any repeat iv fluids are administered since these are the circumstances in which HG patients are most symptomatic. As such, the Study Endpoint will be the mean values from Days 13-14 or, for subjects requiring repeat iv hydration after hospital discharge but before Day 14, the Study Endpoint will be the mean values over the 48 hours prior to this repeat iv hydration administration. Subjects enrolled as outpatients who require repeat iv hydration before study Day 14 will also have a Study Endpoint consisting of the 48 hours prior to the repeat iv hydration administration. Utilizing this flexible Study Endpoint will be an extremely important feature of this study's design since it will avoid including the confounding variables of hospital admission and iv hydration in the data analysis. HG inpatients are typically discharged after 2-5 days.
Secondary Outcome Measures:
- Mean percent change from Baseline to the Study Endpoint in daily nausea and emesis/retching scores individually from the Motherisk-PUQE and from the raw data. [ Time Frame: 2 weeks ]
- Mean percent change from Baseline to the Study Endpoint in daily oral nutrition scores. [ Time Frame: 2 weeks ]
- For subjects enrolled as inpatients, number of days from enrollment to hospital discharge. [ Time Frame: 2 weeks ]
- Percent of subjects requiring repeat iv hydration or hospital admission for HG from the outpatient setting. [ Time Frame: 2 weeks ]
- Mean percent change in NVPQOL questionnaire scores from Baseline to the Study Endpoint. [ Time Frame: 2 weeks ]
- Mean satisfaction and mean relief scores at the Study Endpoint as determined by the Satisfaction Questionnaire. [ Time Frame: 2 weeks ]
- Percent of subjects downgrading from an answer of 3-5 at Baseline to 1-2 at the Study Endpoint on the Hyperemesis Gravidarum Pregnancy Termination Consideration (HGPTC) questionnaire. [ Time Frame: 2 weeks ]
- Percent of subjects choosing to continue their experimental therapy at the Study Endpoint as determined by question 3 on the Satisfaction Questionnaire. [ Time Frame: 2 weeks ]
- Maternal side effects and pregnancy outcomes (maternal complications, term of delivery, mode of delivery, congenital malformations, newborn complications). [ Time Frame: 12 weeks ]
- Mean percent change in laboratory values and weight from Baseline to Day 14. [ Time Frame: 2 weeks ]
- Mean percent change from Baseline to Days 26-28 in daily Motherisk-PUQE and NVPQOL scores (during open-label gabapentin treatment). [ Time Frame: 4 weeks ]
- Mean Satisfaction Questionnaire scores at Day 28. [ Time Frame: 4 weeks ]
- Percent of subjects downgrading from an answer of 3-5 at Baseline to 1-2 at Day 28 on the HGPTC questionnaire. [ Time Frame: 4 weeks ]
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2014 |
| Estimated Study Completion Date: | May 2018 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: gabapentin
1800-2400mg/day divided tid or qid, orally.
|
Drug: Gabapentin
Other Name: Neurontin
|
|
Experimental: metoclopramide
45-60mg/day divided tid or qid, orally
|
Drug: Metoclopramide
Other Name: Reglan
|
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have received at least 2 administrations of intravenous (iv) hydration separated by at least 1 week or daily emesis for at least the last 14 days and 1 administration of iv hydration.
- Have at least one of the following: 3-4+ ketonuria, serum potassium < 3.4mmol, or >5% weight loss from weight upon entry to prenatal care.
- Have failed therapy with at least one antiemetic.
- Have fetal ultrasound within 6 weeks prior to enrollment confirming a normal-appearing, intrauterine, singleton pregnancy of gestational age < 16 weeks at time of enrollment.
- Felt by the patient's obstetrician or emergency room attending physician not to have other medical problems such as bowel obstruction, pancreatitis, biliary colic, or peptic ulcer disease that could be contributing to the patient's symptoms.
- Be >18 years old and not decided to terminate the pregnancy.
- Have not received or planning to receive a peripherally inserted central catheter (PIC line).
- Have a Motherisk-PUQE score of ≥12 for the 24-hour Baseline period.
- Felt not to have any other significant medical, psychiatric or substance abuse problem that would preclude participation in the study.
- Denies drinking any alcohol after learning about current pregnancy.
- Agrees to discontinue any current anti-emetic treatments (including antihistamines, ginger, > 10mg/day vitamin B6, serotonin or dopamine antagonists, anticholinergics, acupuncture, hypnosis, or wrist bands) for the next 4 weeks.
- Pregnancy not conceived through in-vitro fertilization.
- Able to understand and comply with the study procedures and give informed consent.
Exclusion Criteria:
None not mentioned under Inclusion Criteria.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163434
Contacts
| Contact: Thomas Guttuso, Jr., MD | 716-829-5454 | tguttuso@buffalo.edu | |
| Contact: Loralei L Thornburg, MD | (585) 275-7480 | loralei_thornburg@urmc.rochester.edu |
Locations
| United States, New York | |
| University at Buffalo | Recruiting |
| Buffalo, New York, United States, 14214 | |
| Contact: Rachel LaPorta, RN 716-878-7509 rlaporta@buffalo.edu | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Heather Fiore 585-275-7480 Heather_Fiore@URMC.Rochester.edu | |
Sponsors and Collaborators
University at Buffalo
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information
Publications:
| Responsible Party: | Thomas Guttuso, Associate Professor of Neurology, Obstetrics & Gynecology, University at Buffalo |
| ClinicalTrials.gov Identifier: | NCT02163434 History of Changes |
| Other Study ID Numbers: |
496486-3 1R01HD076313-01A1 ( U.S. NIH Grant/Contract ) |
| First Submitted: | June 9, 2014 |
| First Posted: | June 13, 2014 |
| Last Update Posted: | August 4, 2015 |
| Last Verified: | August 2015 |
Keywords provided by Thomas Guttuso, University at Buffalo:
|
pregnancy nausea vomiting hyperemesis |
treatment gabapentin metoclopramide safety |
Additional relevant MeSH terms:
|
Hyperemesis Gravidarum Morning Sickness Pregnancy Complications Vomiting Signs and Symptoms, Digestive Signs and Symptoms Gabapentin gamma-Aminobutyric Acid Metoclopramide Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Antiparkinson Agents |
Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents GABA Agents Antiemetics Autonomic Agents |