Trial Outcomes & Findings for Domperidone for Gastroparesis in Solid Organ Transplantation (NCT NCT00552422)

Results Overview

The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

2 months

Results posted on

2015-07-10

Participant milestones
Measure	Domperidone Arm Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day. domperidone: 10mg orally four times per day
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Domperidone for Gastroparesis in Solid Organ Transplantation

Baseline characteristics by cohort
Measure	Domperidone Arm n=6 Participants Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day. domperidone: 10mg orally four times per day
Age, Customized 18-65	6 participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

Timeframe: 2 months

The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.

Outcome measures
Measure	Domperidone Arm n=6 Participants Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day. domperidone: 10mg orally four times per day
Symptomatic Improvement	6 participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Domperidone n=6 participants at risk Participants ranged from 18-65 years of age. Gender composition was 60$% female and 40% male.
Cardiac disorders long QTc	33.3% 2/6 • Number of events 2 Adverse events were assessed systemically with routine ECG.

Columbia University

Phone: 212-342-4167