Trial Outcomes & Findings for Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies (NCT NCT02263365)
NCT ID: NCT02263365
Last Updated: 2017-12-20
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
30 day
Results posted on
2017-12-20
Participant Flow
Participant milestones
| Measure |
Control
No intervention
|
Therapeutic
Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
18
|
Reasons for withdrawal
| Measure |
Control
No intervention
|
Therapeutic
Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge
|
|---|---|---|
|
Overall Study
Physician Decision
|
22
|
18
|
Baseline Characteristics
Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 30 dayPopulation: Data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 dayPopulation: Data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Data was not collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 dayPopulation: Data was not collected.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapeutic
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