Trial Outcomes & Findings for Effects of Gastric Bypass on Blood Levels of Duloxetine (NCT NCT00989157)

NCT ID: NCT00989157

Last Updated: 2014-08-11

Results Overview

The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72
• Results posted on: 2014-08-11

Participant Flow

Participant milestones

Measure	Control Matched to bariatric subject via BMI, age and gender	Bariatric One year post surgery
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Gastric Bypass on Blood Levels of Duloxetine

Baseline characteristics by cohort

Measure	Bariatric n=10 Participants Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP	Control n=10 Participants Subjects matched to the bariatric subjects via BMI, age and gender	Total n=20 Participants Total of all reporting groups
Age, Continuous	44.10 years STANDARD_DEVIATION 9.02 • n=5 Participants	45.9 years STANDARD_DEVIATION 8.54 • n=7 Participants	45 years STANDARD_DEVIATION 8.78 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72

The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.

Outcome measures

Measure	Bariatric n=10 Participants Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP	Control n=10 Participants Subjects matched to the bariatric subjects via BMI, age and gender
Cmax	51.04 ng/ml Standard Deviation 11.88	61.41 ng/ml Standard Deviation 34.93

PRIMARY outcome

Timeframe: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72

Time to maximum plasma concentration

Outcome measures

Measure	Bariatric n=10 Participants Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP	Control n=10 Participants Subjects matched to the bariatric subjects via BMI, age and gender
Tmax	2.2 Hours Standard Deviation 0.86	6 Hours Standard Deviation 2.17

PRIMARY outcome

Timeframe: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72

Area under the plasma concentration time curve

Outcome measures

Measure	Bariatric n=10 Participants Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP	Control n=10 Participants Subjects matched to the bariatric subjects via BMI, age and gender
AUCo-inf,	646.74 ng h/mL Standard Deviation 79.70	1119.91 ng h/mL Standard Deviation 593.40

PRIMARY outcome

Timeframe: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72

Half life

Outcome measures

Measure	Bariatric n=10 Participants Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP	Control n=10 Participants Subjects matched to the bariatric subjects via BMI, age and gender
T1/2	12.0 hours Standard Deviation 0.87	11.75 hours Standard Deviation 2.38

SECONDARY outcome

Timeframe: 4 days

episodes of emesis.

Outcome measures

Measure	Bariatric n=10 Participants Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP	Control n=10 Participants Subjects matched to the bariatric subjects via BMI, age and gender
Emesis	2 number of occurences	3 number of occurences

Adverse Events

Bariatric

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bariatric n=10 participants at risk Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP	Control n=10 participants at risk Subjects matched to the bariatric subjects via BMI, age and gender
Gastrointestinal disorders Emesis	20.0% 2/10 • Number of events 2	30.0% 3/10 • Number of events 3

Additional Information

Dr. James Roerig

NRIFargo

Phone: 701 365 4919

Email: jroerig@nrifargo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place