Trial Outcomes & Findings for A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects (NCT NCT01015976)
NCT ID: NCT01015976
Last Updated: 2014-03-31
Results Overview
AUC of surgery group compared to the AUC of control group
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours
Results posted on
2014-03-31
Participant Flow
Participant milestones
| Measure |
Experimental
Post surgery group Sertraline : Single dose of 100mg sertraline
|
Control Group
active drug
No surgery matched subjects
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects
Baseline characteristics by cohort
| Measure |
Active Drug
n=10 Participants
Single arm study, all receive active drug
Sertraline : Single dose of 100mg sertraline
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hoursPopulation: Per protocol
AUC of surgery group compared to the AUC of control group
Outcome measures
| Measure |
Control
n=10 Participants
Single arm study, all receive active drug
Sertraline : Single dose of 100mg sertraline
|
|---|---|
|
AUC Post Surgery (n =5) Compared to AUC Control (n=5)
Post surgery
|
124.4 ng-hr/mL
Standard Deviation 55.5
|
|
AUC Post Surgery (n =5) Compared to AUC Control (n=5)
Control
|
314.8 ng-hr/mL
Standard Deviation 129.6
|
Adverse Events
Active Drug
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
James L. Roerig PharmD, BCPP
University of North Dakota - Neuropsychiatric Research Institute
Phone: 701 365 4919
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place