Effects of Gastric Bypass on Blood Levels of Duloxetine
Information source: Neuropsychiatric Research Institute, Fargo, North Dakota
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Bypass
Intervention: Duloxetine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Neuropsychiatric Research Institute, Fargo, North Dakota Official(s) and/or principal investigator(s):
James L Roerig, PharmD, BCPP, Principal Investigator, Affiliation: Neuropsychiatric Research Institute and University of North Dakota
Overall contact:
Joshua C Johnson, BA, Phone: 701-365-4970, Email: jjohnson@nrifargo.com
Summary
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.
Clinical Details
Official title: A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: 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.
Secondary outcome: Assessment of subject tolerance of duloxetine utilizing the UKU side effect rating scale.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Joshua C Johnson, BA, Phone: 701-365-4970, Email: jjohnson@nrifargo.com
Neuropsychiatric Research Institute, Fargo, North Dakota 58103, United States; Recruiting
Joshua C Johnson, BA, Phone: 701-365-4970, Email: jjohnson@nrifargo.com
Jennifer J Barker, MBA, Phone: 701-365-4949, Email: jbarker@nrifargo.com
Additional Information
Neuropsychiatric Research Institute
Starting date: September 2009
Last updated: June 29, 2010
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