Roux en Y Gastric Bypass SurgeryPhase 3NCT01214382
Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery
A Phase 3 study testing Sertraline in people with Roux en Y Gastric Bypass Surgery, run by North Dakota State University at 1 site in United States.
Trial summary
This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Roux en Y Gastric Bypass Surgery
- What is being tested?
- Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- 1. Male or female between 18 and 60 years of age at the time of Informed Consent
- 2. Scheduled to undergo Roux en Y Gastric Bypass Surgery (RYGBP) or in evaluation for surgery prior to scheduling at the investigators' discretion.
- 3. Ability to swallow whole medication tablets and eat solid foods
Who cannot join
- 1. Those taking any medication at the time of the study which has a known, clinically significant, drug-interaction with sertraline, which may affect participant safety or threaten the validity of the data.
- 2. Hypersensitivity to sertraline or any excipient contained in either the tablet or solution
- 3. Inability to tolerate blood draws
- 4. History of or current bipolar disorder, psychotic disorder, or current major depressive disorder or suicidality, or other psychiatric condition that the investigator feels may put the subject at additional risk by participating in the study
- 5. Alcohol or other substance abuse in the past four weeks or dependence in the past year
- 6. Currently pregnant or lactating or any participant who wants to become pregnant during the study
Show all 17Show fewer
- 7. Female participant unwilling to use an accepted method of birth control during the study assessment periods.
- 8. Disulfiram or metronidazole at baseline (due to small percentage of alcohol in sertraline solution) or other medication with a similar interaction with a very small amount of alcohol
- 9. Inability or unwillingness to avoid alcohol or grapefruit juice for the required study duration
- 10. Baseline medications which significantly alter gastrointestinal transit time (e.g. oral anticholinergic medications, metoclopramide, erythromycin) and are taken on a routinely scheduled basis. In addition, any such medication cannot be taken in close proximity (minimum of five half-lives of the drug) to the study sertraline administration.
- 11. Medical condition which may increase participant risk with sertraline
- 12. Hepatic insufficiency (Hepatic insufficiency will be defined as any liver enzyme test on a standard hepatic panel of greater than or equal to twice the upper limit of normal, or any other hepatic abnormality identified on physical exam, self-report, or laboratory testing that puts the participant at risk in the opinion of the study physician or physician assistant.)
- 13. History of daily tobacco product use in the past six months
- 14. Participants who have undergone any type of prior surgical procedure for weight loss
- 15. Significant Latex allergy (liquid form has a latex dropper)
- 16. Participant employed by, or who has immediate family employed by NRI
- 17. History of Hepatitis or HIV Infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuropsychiatric Research Institute
Fargo, North Dakota, 58103
About this study
Official title: A Prospective, Longitudinal Comparison of the Pharmacokinetic Properties of Sertraline Before and After Roux-en-Y Gastric Bypass
This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Participants will be asked to take part in this study at three time points: 1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve months following surgery. This study will enroll approximately 30 participants.
- Conditions
- Roux en Y Gastric Bypass Surgery
- Being tested
- Sertraline
- Keywords
- Gastric Bypass, Bariatric Surgery, Sertraline, Zoloft, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
Single dose sertraline 100 mg, tablet and solution
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Experimental | Not described Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC)
The primary aim of this research is to provide a prospective, longitudinal comparison of pharmacokinetic measures associated with a single-dose of sertraline in RYGBP patients. Comparisons will be based upon sertraline plasma concentrations obtained prior to surgery and repeated at three and 12 months following surgery. A 24+ month post-surgery follow-up to evaluate sertraline tablet AUC will be offered to a subset of study volunteers.
Measured: 72 hour intervals
Secondary outcomes (4)
Bioavailability comparison between sertraline tablet and sertraline liquid
To characterize the relative bioavailability of the tablet formulation of sertraline 100mg as compared to a reference dose of the liquid preparation of sertraline 100mg before and at three and 12 months following RYGBP.
Measured: 72 hours
Body Composition and Weight
Chanes in body compsition and weight will be correlated with changes observed in sertraline pharmacokinetic parameters and will be considered exploratory.
Measured: 72 hours
Hepatic Function
To assess the area under the curve (AUC) ratio of N-desmethylsertraline to sertraline as a measure of hepatic function over time.
Measured: 72 hours
Plasma Protein Concentrations
To assess changes over time in common drug binding plasma proteins in relationship to observed sertraline plasma levels.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Roux en Y Gastric Bypass 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kristine Steffen, Neuropsychiatric Research Institute, Fargo, North Dakota
- Investigators
- Kristine J Steffen, Pharm.D., Ph.D., Principal investigator, Neuropsychiatric Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214382
- Sponsor's protocol ID
- 1K23DK085066-01
- Status last verified
- Apr 2016
- First submitted
- 30 Sep 2010
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Longitudinal Comparison of the Pharmacokinetic Properties of Sertraline Before and After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT01214382
- Acronym / sponsor ID
- 1K23DK085066-01
- Conditions
- Roux en Y Gastric Bypass Surgery
- Keywords
- Gastric Bypass, Bariatric Surgery, Sertraline, Zoloft, Pharmacokinetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Participants will be asked to take part in this study at three time points: 1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve months following surgery. This study will enroll approximately 30 participants.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Experimental | Drug: Sertraline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Male or female between 18 and 60 years of age at the time of Informed Consent
- 2. Scheduled to undergo Roux en Y Gastric Bypass Surgery (RYGBP) or in evaluation for surgery prior to scheduling at the investigators' discretion.
- 3. Ability to swallow whole medication tablets and eat solid foods
Key exclusion criteria (17 listed)
- 1. Those taking any medication at the time of the study which has a known, clinically significant, drug-interaction with sertraline, which may affect participant safety or threaten the validity of the data.
- 2. Hypersensitivity to sertraline or any excipient contained in either the tablet or solution
- 3. Inability to tolerate blood draws
- 4. History of or current bipolar disorder, psychotic disorder, or current major depressive disorder or suicidality, or other psychiatric condition that the investigator feels may put the subject at additional risk by participating in the study
- 5. Alcohol or other substance abuse in the past four weeks or dependence in the past year
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 |
|---|---|---|
| SertralineAlso: ZoloftSingle dose sertraline 100 mg, tablet and solution | Drug | Sertraline |
Primary outcome
Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC)
Time frame: 72 hour intervals
The primary aim of this research is to provide a prospective, longitudinal comparison of pharmacokinetic measures associated with a single-dose of sertraline in RYGBP patients. Comparisons will be based upon sertraline plasma concentrations obtained prior to surgery and repeated at three and 12 months following surgery. A 24+ month post-surgery follow-up to evaluate sertraline tablet AUC will be offered to a subset of study volunteers.
4 secondary outcomes
Bioavailability comparison between sertraline tablet and sertraline liquid
Time frame: 72 hours
Body Composition and Weight
Time frame: 72 hours
Hepatic Function
Time frame: 72 hours
Plasma Protein Concentrations
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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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.
Kristine J Steffen, Pharm.D., Ph.D. principal investigator
Neuropsychiatric Research Institute
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 Sertraline in people with Roux en Y Gastric Bypass Surgery, run by North Dakota State University 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 3 inclusion and 17 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 6 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sertraline Plasma Concentrations/Area-Under-the-Curve (AUC) (time frame: 72 hour intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2016.