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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD076313-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gabapentin | Experimental | 1800-2400mg/day divided tid or qid, orally. |
|
| metoclopramide | Experimental | 45-60mg/day divided tid or qid, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug |
|
| |
| Metoclopramide |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7 |
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Inclusion Criteria:
Exclusion Criteria:
None not mentioned under Inclusion Criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14214 | United States | ||
| University of Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20015600 | 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. | |
| 22730257 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | 1800-2400mg/day divided tid or qid, orally. Gabapentin |
| FG001 | Metoclopramide | 45-60mg/day divided tid or qid, orally Metoclopramide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | 1800-2400mg/day divided tid or qid, orally. Gabapentin |
| BG001 | Metoclopramide | 45-60mg/day divided tid or qid, orally Metoclopramide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | 1 week |
|
|
1 week of double-blind therapy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin | 1800-2400mg/day divided tid or qid, orally. Gabapentin | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Guttuso, Jr. | University at Buffalo | 7169326080 | tguttuso@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2016 | Dec 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006939 | Hyperemesis Gravidarum |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D048968 | Morning Sickness |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Drug |
|
|
Score range: 0-15 with higher score indicating a better outcome.
| 1 week |
| Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting. | 1 week |
| Global Satisfaction of Treatment at the Study Endpoint. | Score range: 0-4 with higher score indicating a better outcome. | 1 week |
| Desire to Continue Therapy at Study Endpoint | Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome. | 1 week |
| Rochester |
| New York |
| 14642 |
| United States |
| 24668130 | 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. |
| 33451591 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | 1 week |
|
|
|
|
| Secondary | Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7 | Score range: 0-15 with higher score indicating a better outcome. | Posted | Mean | Standard Error | units on a scale | 1 week |
|
|
|
|
| Secondary | Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Global Satisfaction of Treatment at the Study Endpoint. | Score range: 0-4 with higher score indicating a better outcome. | Posted | Mean | Standard Error | units on a scale | 1 week |
|
|
|
|
| Secondary | Desire to Continue Therapy at Study Endpoint | Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome. | Posted | Mean | Standard Error | units on a scale | 1 week |
|
|
|
|
| 12 |
| 0 |
| 12 |
| 4 |
| 15 |
| EG001 | Metoclopramide | 45-60mg/day divided tid or qid, orally Metoclopramide | 0 | 9 | 0 | 9 | 3 | 16 |
| Hot Flashes | Endocrine disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |