Bariatric Surgery CandidatePhase 4OBS-2011/001NCT03378960
Study to Compare the Bioavailability of Omeprazole 20 mg Before and After Undergoing Surgery for Morbid Obesity
A Phase 4 study testing Omeprazole 20mg in people with Bariatric Surgery Candidate, run by Emilio Vargas Castrillón at 1 site in Spain.
Trial summary
The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability of omeprazole 20 mg at one month and six months after surgery. Other objectives were: To compare bioavailability of omeprazole 20 mg between patients undergo gastric bypass surgery and patients who avoid it. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Omeprazole 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 31 Oct 2014to 29 Feb 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who wish to participate in the study (men and women) after receiving adequate information about the study design, objectives and risks by signing and date of the written informed consent.
- Age between 18 and 60 years old.
- Patients who come to the endocrinology and nutrition Service and on treatment with omeprazole.
- Patients who are to undergo bariatric surgery (Roux en Y gastric bypass) according to the recommendations of Endocrinology and Nutrition Service and the Department of General Surgery and Digestive Diseases hospital Clinico San Carlos.
- No significant abnormalities on clinical examination and laboratory analysis before inclusion in the study.
Who cannot join
- Any postoperative complication that interferes with the regular intake of medication such as stenosis of anastomotic, fistula, persistent vomiting, diarrhea (> 4 stools per day), evidence of protein malnutrition (albumin <3.5 g / l).
- High consumption of stimulating beverages (equivalent to 400 mg of caffeine per day, a cup of coffee contains approximately 100 mg of caffeine).
- Consumption of any medication that may interfere with the objectives of the study: * Use of enzyme inhibitors or inducers within 2 weeks prior to study inclusion (barbiturates, carbamazepine, erythromycin, phenytoin, oral contraceptives, etc.) * Any concomitant medication will be assessed by the investigator based on data recorded in the log-book for the medication (potential interactions) and registered in the CRF.
- History of clinically significant disease in the opinion of the investigator does not allow safe participation of the patient.
- Inability to relate to and / or cooperate with investigators.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Madrid, 28040
About this study
Official title: Bioavailability Study of Omeprazole (20 mg) at Steady State (Multiple Dose) in Patients Who Have Undergone Bariatric Surgery
The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability of omeprazole 20 mg at one month and six months after surgery.
Other objectives were:
Read more
- To compare bioavailability of omeprazole 20 mg between patients undergo gastric bypass surgery and patients who avoid it.
- To asses other pharmacokinetic parameters, demographic parameters and drug safety.
Study design It was planned a mixed design which intended to compare the bioavailability in patients with gastric bypass (before and after surgery) and control subjects matched by sex and body mass index (BMI) post-surgery. This was a single-dose, open-label, crossover bioavailability study of omeprazole in surgical group and controls.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Omeprazole 20mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole 20mgDrug
| Study group | Role | What they receive |
|---|---|---|
| omeprazole | Other | omeprazole 20 mg Receives: Drug: Omeprazole 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC variation Pharmacokinetic parameters
Omeprazole Biodisponibility
Measured: Baseline and 6 month after bariatric surgery
Tmax variation
Time required to reach the maximum concentration of Omeprazole in blood after its administration.
Measured: Baseline and 6 month after bariatric surgery
Cmax variation
Maximum concentration of Omeprazole in blood after its administration.
Measured: Baseline and 6 month after bariatric surgery
Secondary outcomes (3)
AUC 1 month
Omeprazole Biodisponibility
Measured: 1 month after surgery
Tmax 1 month
Time required to reach the maximum concentration of Omeprazole in blood after its administration
Measured: 1 month after surgery
Cmax 1 month
Maximum concentration of Omeprazole in blood after its administration.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start31 Oct 2014
- Primary completion23 Dec 2015
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Primary purpose
- Other
- Intervention model
- Sequential
- Model description
- This was a single-dose, open-label, bioavailability study of surgical group and controls.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emilio Vargas Castrillón
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Responsible party
- Sponsor-investigator, Emilio Vargas Castrillón, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378960
- Sponsor's protocol ID
- OBS-2011/001
- Acronym
- OBS-2011/001
- Status last verified
- Feb 2019
- First submitted
- 27 Nov 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study of Omeprazole (20 mg) at Steady State (Multiple Dose) in Patients Who Have Undergone Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03378960
- Acronym / sponsor ID
- OBS-2011/001 / OBS-2011/001
- Conditions
- Bariatric Surgery Candidate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Emilio Vargas CastrillónUniversity, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Study start
- 31 Oct 2014 (actual)
- Primary completion
- 23 Dec 2015 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 20 Dec 2017 (actual)
- 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.
The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability of omeprazole 20 mg at one month and six months after surgery.
Other objectives were:
- To compare bioavailability of omeprazole 20 mg between patients undergo gastric bypass surgery and patients who avoid it.
- To asses other pharmacokinetic parameters, demographic parameters and drug safety.
Study design It was planned a mixed design which intended to compare the bioavailability in patients with gastric bypass (before and after surgery) and control subjects matched by sex and body mass index (BMI) post-surgery. This was a single-dose, open-label, crossover bioavailability study of omeprazole in surgical group and controls.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a single-dose, open-label, bioavailability study of surgical group and controls.
| Arm | Type | Receives |
|---|---|---|
| omeprazole | Other | Drug: Omeprazole 20mgomeprazole 20 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who wish to participate in the study (men and women) after receiving adequate information about the study design, objectives and risks by signing and date of the written informed consent.
- Age between 18 and 60 years old.
- Patients who come to the endocrinology and nutrition Service and on treatment with omeprazole.
- Patients who are to undergo bariatric surgery (Roux en Y gastric bypass) according to the recommendations of Endocrinology and Nutrition Service and the Department of General Surgery and Digestive Diseases hospital Clinico San Carlos.
- No significant abnormalities on clinical examination and laboratory analysis before inclusion in the study.
Key exclusion criteria (5 listed)
- Any postoperative complication that interferes with the regular intake of medication such as stenosis of anastomotic, fistula, persistent vomiting, diarrhea (> 4 stools per day), evidence of protein malnutrition (albumin <3.5 g / l).
- High consumption of stimulating beverages (equivalent to 400 mg of caffeine per day, a cup of coffee contains approximately 100 mg of caffeine).
- Consumption of any medication that may interfere with the objectives of the study: * Use of enzyme inhibitors or inducers within 2 weeks prior to study inclusion (barbiturates, carbamazepine, erythromycin, phenytoin, oral contraceptives, etc.) * Any concomitant medication will be assessed by the investigator based on data recorded in the log-book for the medication (potential interactions) and registered in the CRF.
- History of clinically significant disease in the opinion of the investigator does not allow safe participation of the patient.
- Inability to relate to and / or cooperate with investigators.
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 |
|---|---|---|
| Omeprazole 20mg | Drug | omeprazole |
Primary outcome
AUC variation Pharmacokinetic parameters
Time frame: Baseline and 6 month after bariatric surgery
Omeprazole Biodisponibility
Tmax variation
Time frame: Baseline and 6 month after bariatric surgery
Time required to reach the maximum concentration of Omeprazole in blood after its administration.
Cmax variation
Time frame: Baseline and 6 month after bariatric surgery
Maximum concentration of Omeprazole in blood after its administration.
3 secondary outcomes
AUC 1 month
Time frame: 1 month after surgery
Tmax 1 month
Time frame: 1 month after surgery
Cmax 1 month
Time frame: 1 month after surgery
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 25 Feb 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Omeprazole 20mg in people with Bariatric Surgery Candidate, run by Emilio Vargas Castrillón at 1 site in Spain.
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 5 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 25 Feb 2019. 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 Spain. 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?
AUC variation Pharmacokinetic parameters (time frame: Baseline and 6 month after bariatric surgery). The study lists 3 primary outcomes in all. 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 25 Feb 2019.