Trial Outcomes & Findings for Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis (NCT NCT01711918)
NCT ID: NCT01711918
Last Updated: 2018-02-09
Results Overview
A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
COMPLETED
NA
9 participants
Baseline and End of study (2 years or last visit if patient withdraws)
2018-02-09
Participant Flow
Participant milestones
| Measure |
Domperidone
Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
Baseline characteristics by cohort
| Measure |
Domperidone
n=9 Participants
Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and End of study (2 years or last visit if patient withdraws)A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
Outcome measures
| Measure |
Domperidone
n=7 Participants
Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.
|
|---|---|
|
Improvement of Overall Symptoms Based on Likert Scale
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and End of study (2 years or last visit if patient withdraws)A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
Outcome measures
| Measure |
Domperidone
n=7 Participants
Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.
|
|---|---|
|
Improvement of Nausea Based on Likert Scale
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and End of study (2 years or last visit if patient withdraws)A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
Outcome measures
| Measure |
Domperidone
n=7 Participants
Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.
|
|---|---|
|
Improvement of Vomiting Based on Likert Scale
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and End of study (2 years or last visit if patient withdraws)A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
Outcome measures
| Measure |
Domperidone
n=7 Participants
Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.
|
|---|---|
|
Improvement of Abdominal Bloating or Distention Based on Likert Scale
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and End of study (2 years or last visit if patient withdraws)A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
Outcome measures
| Measure |
Domperidone
n=7 Participants
Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.
|
|---|---|
|
Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale
|
1 Participants
|
Adverse Events
Domperidone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Domperidone
n=7 participants at risk
Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Allergic Reaction
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Partial Bowel Obstruction
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
28.6%
2/7 • Number of events 3
|
|
Reproductive system and breast disorders
Ruptured Right Ovarian Cyst
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Migraine
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
1/7 • Number of events 1
|
|
Ear and labyrinth disorders
Dizziness
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shaking
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest Pain
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Hand Tingling
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Dry Mouth
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Chest Palpitations
|
14.3%
1/7 • Number of events 1
|
|
Hepatobiliary disorders
Elevated ALT
|
14.3%
1/7 • Number of events 1
|
|
Hepatobiliary disorders
Elevated AST
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place