Effects of Gastric Bypass on Blood Levels of Duloxetine

This study has been completed.
Sponsor:
Collaborators:
University of North Dakota
Eli Lilly and Company
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier:
NCT00989157
First received: October 1, 2009
Last updated: February 13, 2014
Last verified: February 2014

October 1, 2009
February 13, 2014
September 2009
October 2012   (final data collection date for primary outcome measure)
The difference, if any, in the pharmacokinetics parameters (Cmax, Tmax, AUCo-inf, t1/2, CL/F, Vd/F) 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. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00989157 on ClinicalTrials.gov Archive Site
Assessment of subject tolerance of duloxetine utilizing the UKU side effect rating scale. [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Gastric Bypass on Blood Levels of Duloxetine
A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine

This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.

Not Provided
Interventional
Phase 3
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Gastric Bypass
Drug: Duloxetine
Single dose of 60 mg of duloxetine
Other Name: Cymbalta
Experimental: Active drug
All subjects received drug. Single arm.
Intervention: Drug: Duloxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects between the ages of 18 and 60 years.
  • Subjects must be of good general health by history and physical exam.
  • Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y procedure), no BMI requirement.
  • Ten normal control subjects who have met the inclusion criteria and have not received bariatric surgery and who are matched to the surgery subjects according to body mass index, age and sex.
  • Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
  • No contraindications to receiving a single capsule of 60 mg of duloxetine

Exclusion Criteria:

  • Allergy to duloxetine or any of its constituents.
  • Candidates who are pregnant or nursing
  • Candidates currently receiving any antidepressant.
  • Candidates that are determined to be poor metabolizers for CYP2D6
  • Subjects who smoke or use any nicotine products
  • Candidates currently receiving a medication that interacts with duloxetine.
  • Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.
  • Candidates experiencing or with a history of vomiting or diarrhea associated with bariatric surgery
  • Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder.
  • Candidates who have participated in an investigational drug study in past 30 days.
  • Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00989157
F1J-US-X054
Not Provided
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
Neuropsychiatric Research Institute, Fargo, North Dakota
  • University of North Dakota
  • Eli Lilly and Company
Principal Investigator: James L Roerig, PharmD, BCPP Neuropsychiatric Research Institute and University of North Dakota
Neuropsychiatric Research Institute, Fargo, North Dakota
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP