A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects

NCT01015976 | Completed Phase 3 Results

• 1 other identifier: 200803-272
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the difference, if any, in the area under the sertraline plasma level time curve (AUC) 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.

Conditions

Obesity

Keywords

Gastric Bypass; Sertraline; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• AUC Post Surgery (n =5) Compared to AUC Control (n=5)

  AUC of surgery group compared to the AUC of control group

  0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours

Study Arms (2)

Post bariatric surgery

EXPERIMENTAL

Roux en Y bariatric surgery

Procedure: bariatric surgery

Control

OTHER

No surgery

Other: control

Interventions

bariatric surgery PROCEDURE

Roux en Y bariatric surgery

Post bariatric surgery

control OTHER

No surgery

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects between the ages of 18 and 60 years.
• Subjects must be of good general health by history and physical exam.
• Five subjects 9 to 15 months past bariatric surgery (Roux-en-Y procedure), no BMI requirement.
• Five subjects matched for body mass index, age and sex to the post bariatric surgery group.
• No contraindications to receiving a single dose of 100 mg of sertraline.
• Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraception) and have a negative pregnancy test at baseline.

You may not qualify if:

• Allergy to sertraline or any of its constituents.
• Candidates currently receiving sertraline or any other antidepressant.
• Candidates currently receiving a medication that interacts with sertraline (Zoloft)
• Candidates who are poor metabolizers for the CYP2D6 and/or 2C19 enzymes.
• Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.
• 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.
• Candidates who are pregnant or nursing at time of study.

Sponsors & Collaborators

• Neuropsychiatric Research Institute, Fargo, North Dakota: lead
• University of North Dakota: collaborator

Study Sites (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Location

Related Links

• Neuropsychiatric Research Institute

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Limitations and Caveats

small sample size absence of men in either group. short data collection period, characterization of the linear elimination phase of the AUC was not possible.

Results Point of Contact

• Title: James L. Roerig PharmD, BCPP
• Organization: University of North Dakota - Neuropsychiatric Research Institute

jroerig@nrifargo.com

701 365 4919

Study Officials

• James Roerig, PharmD, BCPP

  Neuropsychiatric Research Institute and University of North Dakota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James L. Roerig, Pharm.D., BCPP, University of North Dakota Department of Clinical Neuroscience, Grand Forks, ND and the Neuropsychiatric Research Institute, Fargo, ND.

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: November 18, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 31, 2014
• Results First Posted: March 31, 2014

Record last verified: 2014-02

Locations

US (1)