Postoperative Bariatric SurgeryPhase 4NCT00608712
Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
A Phase 4 study testing Esomeprazole in people with Postoperative Bariatric Surgery, run by AstraZeneca.
Trial summary
Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery for body weight reduction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Bariatric Surgery
- What is being tested?
- Esomeprazole
- Type of treatment
- Pill or oral medicine
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Aug 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent signed and dated
- BMI ≥40 kg/m2 or BMI between 35 and 40 kg/m2, but with a severe disease together with obesity
- Indication for gastric bypass surgery
- Upper digestive endoscopy prior to surgery not showing esophagitis, erosions, ulcers or neoplasia, examination performed up to 30 days before surgery being considered valid
- Helicobacter pylori non-infected patients, diagnosed by tests carried out up to 30 days before surgery
Who cannot join
- Contraindication for gastric bypass surgery
- Contraindication to use Omeprazole and derivatives
- Patients carriers of gastrinoma or having hypergastrinemia
- Patients contraindicated to perform UDE
- Patients with previous esophagogastroduodenal surgery
About this study
Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery for body weight reduction
- Conditions
- Postoperative Bariatric Surgery
- Being tested
- Esomeprazole
- Keywords
- bariatric surgery, ulcer prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
Esomeprazole 20mg oral tablet
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss
Secondary outcomes (1)
To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startNov 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608712
- Sponsor's protocol ID
- D9612L00097
- Status last verified
- Jan 2011
- First submitted
- 23 Jan 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
- ClinicalTrials.gov ID
- NCT00608712
- Acronym / sponsor ID
- D9612L00097
- Conditions
- Postoperative Bariatric Surgery
- Keywords
- bariatric surgery, ulcer prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 6 Feb 2008 (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.
Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery for body weight reduction
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent signed and dated
- BMI ≥40 kg/m2 or BMI between 35 and 40 kg/m2, but with a severe disease together with obesity
- Indication for gastric bypass surgery
- Upper digestive endoscopy prior to surgery not showing esophagitis, erosions, ulcers or neoplasia, examination performed up to 30 days before surgery being considered valid
- Helicobacter pylori non-infected patients, diagnosed by tests carried out up to 30 days before surgery
Key exclusion criteria (5 listed)
- Contraindication for gastric bypass surgery
- Contraindication to use Omeprazole and derivatives
- Patients carriers of gastrinoma or having hypergastrinemia
- Patients contraindicated to perform UDE
- Patients with previous esophagogastroduodenal surgery
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 |
|---|---|---|
| EsomeprazoleAlso: NexiumEsomeprazole 20mg oral tablet | Drug | – |
Primary outcome
To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss
1 secondary outcome
To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss.
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 24 Jan 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole in people with Postoperative Bariatric Surgery, run by AstraZeneca.
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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss. 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 24 Jan 2011.