Duodenal UlcerNCT01199536
Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers
An observational study of Duodenal Ulcer, run by AstraZeneca at 1 site in Russia.
Trial summary
The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Ulcer
- How many people
- 59 participants
- Where
- 1 siteRussia
- Study dates
- Nov 2010to Nov 2013
- Phase
- Observational
- 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
Study population: Hospital patients
Who may be able to join
- Active duodenal ulcer with duodenal ulcer exacerbation confirmed by endoscopic signs of duodenal ulcer disease (acute ulcer or scar deformity of the duodenal bulb) and anamnesis data.
- Helicobacter pylori positive diagnosis at entry by 13C-Urea Breath Test (UBT)
- Prescription of the standard 7-day eradication therapy including esomeprazole 20 mg bd, amoxicillin 1000 mg bd, clarithromycin 500 mg bd
- Written informed consent provided prior the start of participation in the study.
Who cannot join
- Subjects who are unwilling or unable to provide informed consent
- Current complication of duodenal ulcer disease, e.g. perforation, bleeding or pyloric stenosis
- History of esophageal/gastric/duodenal surgery except of the patients underwent perforated ulcer closure or endoscopic hemostasis more than 6 months ago
- Contraindications to Esomeprazole, Amoxicillin or Clarythromycin including known or suspected hypersensitivity or allergy
- Treatment with Amoxicillin, Clarythromycin or Bismuth containing drugs one month prior to inclusion
- Two or more previous attempts to eradicate H. Pylori
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Evaluate Helicobacter Pylori Eradication at the End of Routine Triple Eradication Therapy With Duodenal Ulcer Relapses Control.
The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start
- Conditions
- Duodenal Ulcer
- Keywords
- Helicobacter-positive duodenal ulcer
- Medical subject headings
- Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with Helicobacter-positive duodenal ulcer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of H. pylori at the end routine triple eradication therapy
Measured: 1 year
Secondary outcomes (2)
Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)
Measured: 2 years
Frequency of duodenal ulcer relapses
Frequency of duodenal ulcer relapses based on gastroscopy data and recurrence rate of H.Pylori infection based on breath test data after 52 weeks from the start of the therapy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal UlcerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir T. Ivashkin, Principal investigator, Head of Chair of Internal Diseases Propedeutics and Gastroenterology at MMA n/a I.M. Sechenov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199536
- Sponsor's protocol ID
- NIS-GRU-NEX-2009/1
- Status last verified
- Nov 2013
- First submitted
- 9 Sep 2010
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate Helicobacter Pylori Eradication at the End of Routine Triple Eradication Therapy With Duodenal Ulcer Relapses Control.
- ClinicalTrials.gov ID
- NCT01199536
- Acronym / sponsor ID
- NIS-GRU-NEX-2009/1
- Conditions
- Duodenal Ulcer
- Keywords
- Helicobacter-positive duodenal ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Sep 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.
The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with Helicobacter-positive duodenal ulcer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients
Key inclusion criteria (4 listed)
- Active duodenal ulcer with duodenal ulcer exacerbation confirmed by endoscopic signs of duodenal ulcer disease (acute ulcer or scar deformity of the duodenal bulb) and anamnesis data.
- Helicobacter pylori positive diagnosis at entry by 13C-Urea Breath Test (UBT)
- Prescription of the standard 7-day eradication therapy including esomeprazole 20 mg bd, amoxicillin 1000 mg bd, clarithromycin 500 mg bd
- Written informed consent provided prior the start of participation in the study.
Key exclusion criteria (6 listed)
- Subjects who are unwilling or unable to provide informed consent
- Current complication of duodenal ulcer disease, e.g. perforation, bleeding or pyloric stenosis
- History of esophageal/gastric/duodenal surgery except of the patients underwent perforated ulcer closure or endoscopic hemostasis more than 6 months ago
- Contraindications to Esomeprazole, Amoxicillin or Clarythromycin including known or suspected hypersensitivity or allergy
- Treatment with Amoxicillin, Clarythromycin or Bismuth containing drugs one month prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eradication rate of H. pylori at the end routine triple eradication therapy
Time frame: 1 year
2 secondary outcomes
Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)
Time frame: 2 years
Frequency of duodenal ulcer relapses
Time frame: 2 years
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 Nov 2013.
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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.
Vladimir T. Ivashkin principal investigator
Head of Chair of Internal Diseases Propedeutics and Gastroenterology at MMA n/a I.M. Sechenov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duodenal Ulcer, run by AstraZeneca at 1 site in Russia.
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 4 inclusion and 6 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 Nov 2013. 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 Russia. 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.
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?
Eradication rate of H. pylori at the end routine triple eradication therapy (time frame: 1 year). 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 Nov 2013.