Trial Outcomes & Findings for Reletex for Nausea in GERD Patients (NCT NCT01582100)
NCT ID: NCT01582100
Last Updated: 2014-11-13
Results Overview
number of events of nausea with or without vomiting in patients with GERD in 4 weeks
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
4 weeks
Results posted on
2014-11-13
Participant Flow
two subjects were recruited in clinic. One withdrew after experiencing minor wrist discomfort, the other withdrew after determining the visit schedule undesirable.
Participant milestones
| Measure |
GERD Subjects With Nausea
Subjects who present with GERD along with nausea (with or without vomiting)
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
GERD Subjects With Nausea
Subjects who present with GERD along with nausea (with or without vomiting)
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Reletex for Nausea in GERD Patients
Baseline characteristics by cohort
| Measure |
GERD Subjects With Nausea
n=2 Participants
Subjects who present with GERD along with nausea (with or without vomiting)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksnumber of events of nausea with or without vomiting in patients with GERD in 4 weeks
Outcome measures
Outcome data not reported
Adverse Events
Wrist Discomfort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place