Hyperemesis GravidarumPhase 2NCT02163434
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
A Phase 2 study testing Gabapentin and Metoclopramide in people with Hyperemesis Gravidarum, run by State University of New York at Buffalo at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hyperemesis Gravidarum
- What is being tested?
- Gabapentin and Metoclopramide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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: 2-4+ 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.
Show all 13Show fewer
- 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.
Who cannot join
- None not mentioned under Inclusion Criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University at Buffalo
Buffalo, New York, 14214
University of Rochester
Rochester, New York, 14642
About this study
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.
- Conditions
- Hyperemesis Gravidarum
- Being tested
- Gabapentin, Metoclopramide
- Keywords
- pregnancy, nausea, vomiting, hyperemesis, treatment, gabapentin, metoclopramide, safety
- Medical subject headings
- Hyperemesis Gravidarum, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
MetoclopramideDrug
Also called Reglan
| Study group | Role | What they receive |
|---|---|---|
| gabapentin | Experimental | 1800-2400mg/day divided tid or qid, orally. Receives: Drug: Gabapentin |
| metoclopramide | Experimental | 45-60mg/day divided tid or qid, orally Receives: Drug: Metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7
Score range: 6-30 with higher score indicating a worse outcome.
Measured: 1 week
Secondary outcomes (5)
Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.
Score range: 2-10 with higher score indicating a worse outcome.
Measured: 1 week
Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7
Score range: 0-15 with higher score indicating a better outcome.
Measured: 1 week
Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.
Measured: 1 week
Global Satisfaction of Treatment at the Study Endpoint.
Score range: 0-4 with higher score indicating a better outcome.
Measured: 1 week
Desire to Continue Therapy at Study Endpoint
Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Thomas Guttuso, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163434
- Sponsor's protocol ID
- 496486-3
- Other IDs
- 1R01HD076313-01A1
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2014
- Last updated
- 14 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20015600Holmes 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.
PubMed 22730257Guttuso 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.
PubMed 24668130Guttuso 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.
PubMed 33451591
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT02163434
- Acronym / sponsor ID
- 496486-3
- Conditions
- Hyperemesis Gravidarum
- Keywords
- pregnancy, nausea, vomiting, hyperemesis, treatment, gabapentin, metoclopramide, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2014
- Primary completion
- Oct 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Posted 27 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gabapentin | Experimental | Drug: Gabapentin1800-2400mg/day divided tid or qid, orally. |
| metoclopramide | Experimental | Drug: Metoclopramide45-60mg/day divided tid or qid, orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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: 2-4+ 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.
Key exclusion criteria (1 listed)
- None not mentioned under Inclusion Criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: Neurontin | Drug | gabapentin |
| MetoclopramideAlso: Reglan | Drug | metoclopramide |
Primary outcome
Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7
Time frame: 1 week
Score range: 6-30 with higher score indicating a worse outcome.
5 secondary outcomes
Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.
Time frame: 1 week
Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7
Time frame: 1 week
Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.
Time frame: 1 week
Global Satisfaction of Treatment at the Study Endpoint.
Time frame: 1 week
Desire to Continue Therapy at Study Endpoint
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20015600Guttuso 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: PubMed 22730257Holmes 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: PubMed 24668130Guttuso 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.
- Derived from this study: PubMed 33451591Guttuso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gabapentin and Metoclopramide in people with Hyperemesis Gravidarum, run by State University of New York at Buffalo at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7 (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163434, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.