Trial Outcomes & Findings for Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD) (NCT NCT02185183)
NCT ID: NCT02185183
Last Updated: 2014-10-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
15 weeks
Results posted on
2014-10-01
Participant Flow
Participant milestones
| Measure |
AlequelTM 30 ng Once a Day Orally
AlequelTM 30 ng once a day orally
Alequel: Alequel
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)
Baseline characteristics by cohort
| Measure |
AlequelTM
n=14 Participants
AlequelTM
Alequel: Alequel
|
|---|---|
|
Age, Continuous
|
35 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
Israel
|
14 participants
n=99 Participants
|
|
Crohn's disease activity index
|
303 units on a scale
n=99 Participants
|
PRIMARY outcome
Timeframe: 15 weeksOutcome measures
| Measure |
AlequelTM
n=14 Participants
AlequelTM
Alequel: Alequel
|
|---|---|
|
Number of Participants With Improved in Disease Activity
|
0 participants
|
Adverse Events
AlequelTM
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