Bariatric SurgeryPhase 3NCT00989157

Effects of Gastric Bypass on Blood Levels of Duloxetine

A Phase 3 study testing Duloxetine in people with Bariatric Surgery, run by Neuropsychiatric Research Institute, Fargo, North Dakota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Bariatric Surgery
What is being tested?: Duloxetine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Nov 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Neuropsychiatric Research Institute
Fargo, North Dakota, 58103

Other trials in United States

About this study

Official title: A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine

Conditions: Bariatric Surgery
Being tested: Duloxetine
Keywords: Gastric Bypass, Duloxetine, Cymbalta, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DuloxetineDrug
Also called Cymbalta
Single dose of 60 mg of duloxetine

Study groups in NCT00989157
Study group	Role	What they receive
Active drug	Experimental	All subjects received drug. Single arm. Receives: Drug: Duloxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
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.
Measured: 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
Tmax
Time to maximum plasma concentration
Measured: 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
AUCo-inf,
Area under the plasma concentration time curve
Measured: 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
T1/2
Half life
Measured: 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

Secondary outcomes (1)

Emesis
episodes of emesis.
Measured: 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Nov 2012

First posted2 Oct 2009 (estimated)
Study startSep 2009
Primary completionOct 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00989157
Sponsor's protocol ID: F1J-US-X054
Status last verified: Jul 2014
First submitted: 1 Oct 2009
Last updated: 11 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruiting
Comparison of Intensive and Conservative NOL®-Guided Analgesia Strategies During Opioid-free Anesthesia
Anesthesia, Bariatric Surgery (Gastric Bypass)
Enrolling by invitationObservational study
Changes in Body Composition Following Pharmacological Treatment for Obesity.
Obesity (BMI Equal to or >30), Weight Regain After Bariatric Surgery
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression

All Bariatric Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine
ClinicalTrials.gov ID: NCT00989157
Acronym / sponsor ID: F1J-US-X054
Conditions: Bariatric Surgery
Keywords: Gastric Bypass, Duloxetine, Cymbalta, Pharmacokinetics
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Neuropsychiatric Research Institute, Fargo, North DakotaUniversity, hospital or other
Collaborators: University of North Dakota, Eli Lilly and Company
Study start: Sep 2009
Primary completion: Oct 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 2 Oct 2009 (estimated)
Results: Posted 11 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active drug	Experimental	Drug: DuloxetineAll subjects received drug. Single arm.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DuloxetineAlso: CymbaltaSingle dose of 60 mg of duloxetine	Drug	Active drug

Primary outcome

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.
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
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
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

1 secondary outcome

Emesis
Time frame: 4 days

Results and safety

Results posted to the registry on 11 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	10	10
Bariatric	10	10

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/ml

Measure	Bariatric n = 10	Control n = 10
Value	51.04 (11.88)	61.41 (34.93)

Primary outcome: 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. Mean (Standard Deviation). Unit: Hours

Measure	Bariatric n = 10	Control n = 10
Value	2.2 (0.86)	6 (2.17)

Primary outcome: 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. Mean (Standard Deviation). Unit: ng h/mL

Measure	Bariatric n = 10	Control n = 10
Value	646.74 (79.70)	1119.91 (593.40)

Primary outcome: 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. Mean (Standard Deviation). Unit: hours

Measure	Bariatric n = 10	Control n = 10
Value	12.0 (0.87)	11.75 (2.38)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bariatric	0 of 10 (0%)	2 of 10 (20%)	Not reported
Control	0 of 10 (0%)	3 of 10 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bariatric Surgery

RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruiting
Comparison of Intensive and Conservative NOL®-Guided Analgesia Strategies During Opioid-free Anesthesia
Anesthesia, Bariatric Surgery (Gastric Bypass)
Enrolling by invitationObservational study
Changes in Body Composition Following Pharmacological Treatment for Obesity.
Obesity (BMI Equal to or >30), Weight Regain After Bariatric Surgery
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James L Roerig, PharmD, BCPP principal investigator

Neuropsychiatric Research Institute and University of North Dakota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Duloxetine in people with Bariatric Surgery, run by Neuropsychiatric Research Institute, Fargo, North Dakota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00989157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.