Trial Outcomes & Findings for Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation (NCT NCT01460225)
NCT ID: NCT01460225
Last Updated: 2018-07-13
Results Overview
gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
Day 1 and Day 7
Results posted on
2018-07-13
Participant Flow
19 patients entered the study; no dropouts. All patients completed the study; the entire study was contacted at Dartmouth.
No patients were excluded.
Participant milestones
| Measure |
Lubirprostone
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
Baseline characteristics by cohort
| Measure |
Lubirprostone
n=19 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 7gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)
Outcome measures
| Measure |
Prior to Treatement With Lubiprostone
n=19 Participants
|
Post Treatment With Lubiprostone
n=19 Participants
|
|---|---|---|
|
Gastric Emptying
2 Hours after meal
|
0.27 percent meal retention
Standard Deviation NA
Original Data for this study have been destroyed, the study was not published and the Standard Deviation was not reported with the data in the only report available. A p= .003 was documented. This is the only measure of precision in the report.
|
0.384 percent meal retention
Standard Deviation NA
Original Data for this study have been destroyed, the study was not published and the Standard Deviation was not reported with the data in the only report available. A p= .003 was documented. This is the only measure of precision in the report.
|
|
Gastric Emptying
4 Hours after meal
|
0.04 percent meal retention
Standard Deviation NA
Original Data for this study have been destroyed, the study was not published and the Standard Deviation was not reported with the data in the only report available. A p value was documented and this is the only measure of precision in the report.
|
0.051 percent meal retention
Standard Deviation NA
Original Data for this study have been destroyed, the study was not published and the Standard Deviation was not reported with the data in the only report available. A p value was documented and this is the only measure of precision in the report.
|
Adverse Events
All- Single Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All- Single Arm
n=19 participants at risk
|
|---|---|
|
Gastrointestinal disorders
nausea
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Headache
|
5.3%
1/19 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place