Trial Outcomes & Findings for Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum (NCT NCT02163434)

NCT ID: NCT02163434

Last Updated: 2023-02-14

Results Overview

Score range: 6-30 with higher score indicating a worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2023-02-14

Participant Flow

Participant milestones

Measure	Gabapentin 1800-2400mg/day divided tid or qid, orally. Gabapentin	Metoclopramide 45-60mg/day divided tid or qid, orally Metoclopramide
Overall Study STARTED	15	16
Overall Study COMPLETED	12	9
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Baseline characteristics by cohort

Measure	Gabapentin n=12 Participants 1800-2400mg/day divided tid or qid, orally. Gabapentin	Metoclopramide n=9 Participants 45-60mg/day divided tid or qid, orally Metoclopramide	Total n=21 Participants Total of all reporting groups
Age, Continuous	26.2 years STANDARD_DEVIATION 5.9 • n=93 Participants	26.3 years STANDARD_DEVIATION 3.9 • n=4 Participants	26.25 years STANDARD_DEVIATION 4.5 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	9 Participants n=4 Participants	21 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized non-Hispanic white	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized non-Hispanic black	10 Participants n=93 Participants	6 Participants n=4 Participants	16 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic white	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	12 participants n=93 Participants	9 participants n=4 Participants	21 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 week

Score range: 6-30 with higher score indicating a worse outcome.

Outcome measures

Measure	Gabapentin n=12 Participants 1800-2400mg/day divided tid or qid, orally. Gabapentin	Metoclopramide n=9 Participants 45-60mg/day divided tid or qid, orally Metoclopramide
Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7	6.35 units on a scale Standard Error 2.44	13.22 units on a scale Standard Error 2.39

SECONDARY outcome

Timeframe: 1 week

Score range: 2-10 with higher score indicating a worse outcome.

Outcome measures

Measure	Gabapentin n=12 Participants 1800-2400mg/day divided tid or qid, orally. Gabapentin	Metoclopramide n=9 Participants 45-60mg/day divided tid or qid, orally Metoclopramide
Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.	2.01 units on a scale Standard Error 0.45	3.69 units on a scale Standard Error 0.45

SECONDARY outcome

Timeframe: 1 week

Score range: 0-15 with higher score indicating a better outcome.

Outcome measures

Measure	Gabapentin n=12 Participants 1800-2400mg/day divided tid or qid, orally. Gabapentin	Metoclopramide n=9 Participants 45-60mg/day divided tid or qid, orally Metoclopramide
Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7	7.86 units on a scale Standard Error 1.23	4.01 units on a scale Standard Error 1.34

SECONDARY outcome

Timeframe: 1 week

Outcome measures

Measure	Gabapentin n=12 Participants 1800-2400mg/day divided tid or qid, orally. Gabapentin	Metoclopramide n=9 Participants 45-60mg/day divided tid or qid, orally Metoclopramide
Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 week

Score range: 0-4 with higher score indicating a better outcome.

Outcome measures

Measure	Gabapentin n=12 Participants 1800-2400mg/day divided tid or qid, orally. Gabapentin	Metoclopramide n=9 Participants 45-60mg/day divided tid or qid, orally Metoclopramide
Global Satisfaction of Treatment at the Study Endpoint.	2.22 units on a scale Standard Error 1.56	0.63 units on a scale Standard Error 0.74

SECONDARY outcome

Timeframe: 1 week

Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome.

Outcome measures

Measure	Gabapentin n=12 Participants 1800-2400mg/day divided tid or qid, orally. Gabapentin	Metoclopramide n=9 Participants 45-60mg/day divided tid or qid, orally Metoclopramide
Desire to Continue Therapy at Study Endpoint	0.67 units on a scale Standard Error 0.50	0.14 units on a scale Standard Error 0.38

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Metoclopramide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gabapentin n=15 participants at risk；n=12 participants at risk 1800-2400mg/day divided tid or qid, orally. Gabapentin	Metoclopramide n=16 participants at risk；n=9 participants at risk 45-60mg/day divided tid or qid, orally Metoclopramide
Cardiac disorders Tachycardia	6.7% 1/15 • Number of events 1 • 1 week of double-blind therapy	0.00% 0/16 • 1 week of double-blind therapy
Endocrine disorders Hot Flashes	6.7% 1/15 • Number of events 1 • 1 week of double-blind therapy	0.00% 0/16 • 1 week of double-blind therapy
General disorders fatigue	13.3% 2/15 • Number of events 2 • 1 week of double-blind therapy	0.00% 0/16 • 1 week of double-blind therapy
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 1 • 1 week of double-blind therapy	6.2% 1/16 • Number of events 1 • 1 week of double-blind therapy
Nervous system disorders Headache	0.00% 0/15 • 1 week of double-blind therapy	6.2% 1/16 • Number of events 1 • 1 week of double-blind therapy
Gastrointestinal disorders Diarrhea	0.00% 0/15 • 1 week of double-blind therapy	6.2% 1/16 • Number of events 1 • 1 week of double-blind therapy
Gastrointestinal disorders Abdominal Pain	0.00% 0/15 • 1 week of double-blind therapy	6.2% 1/16 • Number of events 1 • 1 week of double-blind therapy

Additional Information

Dr. Thomas Guttuso, Jr.

University at Buffalo

Phone: 7169326080

Email: tguttuso@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place