ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Gastric Bypass on Blood Levels of Duloxetine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00989157
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Collaborators:
University of North Dakota
Eli Lilly and Company
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Drug: Duloxetine Phase 3

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine
Study Start Date : September 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Active drug
All subjects received drug. Single arm.
 Drug: Duloxetine
Single dose of 60 mg of duloxetine
Other Name: Cymbalta


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cmax [ Time Frame: 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.

  2. Tmax [ Time Frame: 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

  3. AUCo-inf, [ Time Frame: 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

  4. T1/2 [ Time Frame: 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


Secondary Outcome Measures :
  1. Emesis [ Time Frame: 4 days ]
    episodes of emesis.


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989157


Locations
United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58103
Sponsors and Collaborators
Neuropsychiatric Research Institute, Fargo, North Dakota
University of North Dakota
Eli Lilly and Company
Investigators
Principal Investigator: James L Roerig, PharmD, BCPP Neuropsychiatric Research Institute and University of North Dakota
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Neuropsychiatric Research Institute  This link exits the ClinicalTrials.gov site

Responsible Party: James Roerig, James L Roerig, PharmD, BCPP, Neuropsychiatric Research Institute and University of North Dakota, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier: NCT00989157     History of Changes
Other Study ID Numbers: F1J-US-X054
First Posted: October 2, 2009    Key Record Dates
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014
Last Verified: July 2014

Keywords provided by James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota:
Gastric Bypass
Duloxetine
Cymbalta
Pharmacokinetics

Additional relevant MeSH terms:
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents