Roux en Y Gastric BypassPhase 4VLXNCT02005107
Venlafaxine PK Following Bariatric Surgery
A Phase 4 study testing Venlafaxine IR and Venlafaxine XR in people with Roux en Y Gastric Bypass and Sleeve Gastrectomy, 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 immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Roux en Y Gastric Bypass, Sleeve Gastrectomy
- What is being tested?
- Venlafaxine IR and Venlafaxine XR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Mar 2015
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Age 18-65 (inclusive, at time of informed consent)
- No tobacco use in the past three months.
- Underwent Roux-en-Y Gastric Bypass or Sleeve Gastrectomy weight loss surgery 12-36 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI. Criteria for matching will be established at the beginning of the study in consultation with the statistical team and addressed as needed with the input of the biostatistician.
- Ability to read, write and understand English
Who cannot join
- Taking a medication that has a clinically significant interaction with venlafaxine or an interaction that may alter the study data.
- Hypersensitivity to venlafaxine or any excipient contained within the dosage forms
- Inability to tolerate repeated blood draws.
- Any history of bipoloar disorder or a psychotic disorder.
- Current major depressive disorder or current suicidality.
- Alcohol or substance dependence in the past year.
Show all 14Show fewer
- Currently pregnant or lactating or unwillingness to use medically accepted contraception during study
- Taking a medication which significantly alters gastrointesinal transit time or significantly reduces acid secretion (e.g. routine use of proton pump inhibitors, H2 antagonists, sucralfate).
- Medical conditon which may increase participant risk with venlafaxine or uncontrolled hypertension at the discretion of the examining provider.
- Hepatic insufficiency as defined by any hepatic enzyme greater than 3x the upper limit of normal or other hepatic laboratory abnormalities at the discretion of the medical provider.
- Renal impairment as evidence by a calculated creatinine clearance of less than or equal to 70ml/min or other abnormality on a renal panel that the medical provider feels puts the participant at risk.
- Poor or ultra-rapid Cytochrome P450 2D6 metabolizer.
- Self reported history of viral hepatits or HIV.
- Positive urine drug screen unless documented prescription of a non-interacting medication.
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 Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery
This study is being conducted to evaluate how the body absorbs and processes the immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart. This study will enroll up to 30 participants.
- Conditions
- Roux en Y Gastric Bypass, Sleeve Gastrectomy
- Being tested
- Venlafaxine IR and Venlafaxine XR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venlafaxine IR and Venlafaxine XRDrug
Also called Effexor and Effexor XR
| Study group | Role | What they receive |
|---|---|---|
| venlafaxine | Experimental | Venlafaxine IR and XR, single dosages of each separated by a wash-out period Receives: Drug: Venlafaxine IR and Venlafaxine XR |
| Venlafaxine XR and Venlafaxine IR | Other | Each participant (3 groups of participants) will receive one dose of venlafaxine IR and one dose of venlafaxine XR seperated by a wash-out period. Receives: Drug: Venlafaxine IR and Venlafaxine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venlafaxine Plasma Concentrations/Area-Under-the-Curve (AUC)
The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of venlafaxine IR (immediate release) and venlafaxine XR (sustained release) in Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, and matched nonsurgical "control" subjects. Comparisons will be based upon venlafaxine plasma concentrations obtained during the 24 hour sample collection window.
Measured: 24 hours intervals
Secondary outcomes (1)
Secondary PK Characteristics (Composite)
We will also evaluate other PK characteristics associated with venlafaxine, such as Cmax, Tmax, t1/2, and the ratio of venlafaxine to the active metabolite ODV, and others.
Measured: 24 hour collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionMar 2015
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 BypassStudies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Responsible party
- Principal investigator, Kristine Steffen, North Dakota State University
- Investigators
- Kristine J Steffen, Pharm.D., Ph.D., Principal investigator, North Dakota State University & Neuropsychiatric Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005107
- Sponsor's protocol ID
- KSteffenVLX
- Other IDs
- EPSCOR
- Acronym
- VLX
- Status last verified
- Apr 2016
- First submitted
- 3 Dec 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
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 Comparison of Immediate and Extended Release Venlafaxine Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02005107
- Acronym / sponsor ID
- VLX / KSteffenVLX
- Conditions
- Roux en Y Gastric Bypass, Sleeve Gastrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Dec 2013 (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 immediate release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are 1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart. This study will enroll up to 30 participants.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| venlafaxine | Experimental | Drug: Venlafaxine IR and Venlafaxine XRVenlafaxine IR and XR, single dosages of each separated by a wash-out period |
| Venlafaxine XR and Venlafaxine IR | Other | Drug: Venlafaxine IR and Venlafaxine XREach participant (3 groups of participants) will receive one dose of venlafaxine IR and one dose of venlafaxine XR seperated by a wash-out period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female
- Age 18-65 (inclusive, at time of informed consent)
- No tobacco use in the past three months.
- Underwent Roux-en-Y Gastric Bypass or Sleeve Gastrectomy weight loss surgery 12-36 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI. Criteria for matching will be established at the beginning of the study in consultation with the statistical team and addressed as needed with the input of the biostatistician.
- Ability to read, write and understand English
Key exclusion criteria (14 listed)
- Taking a medication that has a clinically significant interaction with venlafaxine or an interaction that may alter the study data.
- Hypersensitivity to venlafaxine or any excipient contained within the dosage forms
- Inability to tolerate repeated blood draws.
- Any history of bipoloar disorder or a psychotic disorder.
- Current major depressive disorder or current suicidality.
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 |
|---|---|---|
| Venlafaxine IR and Venlafaxine XRAlso: Effexor and Effexor XR | Drug | Venlafaxine XR and Venlafaxine IR, venlafaxine |
Primary outcome
Venlafaxine Plasma Concentrations/Area-Under-the-Curve (AUC)
Time frame: 24 hours intervals
The primary aim of this research is to provide a comparison of pharmacokinetic measures associated with a single dose of venlafaxine IR (immediate release) and venlafaxine XR (sustained release) in Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, and matched nonsurgical "control" subjects. Comparisons will be based upon venlafaxine plasma concentrations obtained during the 24 hour sample collection window.
1 secondary outcome
Secondary PK Characteristics (Composite)
Time frame: 24 hour collection
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
North Dakota State University & 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 4 study testing Venlafaxine IR and Venlafaxine XR in people with Roux en Y Gastric Bypass and Sleeve Gastrectomy, 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 5 inclusion and 14 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Venlafaxine Plasma Concentrations/Area-Under-the-Curve (AUC) (time frame: 24 hours 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.