Effects of Gastric Bypass on Blood Levels of Duloxetine
This study has been completed.
Sponsor:
Neuropsychiatric Research Institute, Fargo, North Dakota
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: July 17, 2014
Last verified: July 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bariatric Surgery |
Drug: Duloxetine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Neuropsychiatric Research Institute, Fargo, North Dakota:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]Time to maximum plasma concentration
- 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 ] [ Designated as safety issue: No ]Area under the plasma concentration time curve
- 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 ] [ Designated as safety issue: No ]Half life
Secondary Outcome Measures:
- Emesis [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]episodes of emesis.
| Enrollment: | 20 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Active drug
All subjects received drug. Single arm.
|
Drug: Duloxetine
Single dose of 60 mg of duloxetine
Other Name: Cymbalta
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00989157
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
| 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 |
| Study First Received: | October 1, 2009 |
| Results First Received: | April 8, 2014 |
| Last Updated: | July 17, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 29, 2016