GERDPhase 3NCT00256737
Sopran - Omeprazole Treatment Versus Surgery
A Phase 3 study testing Omeprazole in people with GERD, run by AstraZeneca at 13 sites in 4 countries.
Trial summary
The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Omeprazole
- How many people
- 219 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Jan 1998to Oct 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous inclusion into Astra study I-635 and willing to continue for another 10 years,
Who cannot join
- Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or confirmed malignancy; Documented eradication of Helicobacter pylori.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Denmark6 sites
Research Site
Aalborg
Research Site
Glostrup Municipality
Research Site
Hillerød
Research Site
Kolding
Research Site
Odense
Research Site
Roskilde
Sweden3 sites
Research Site
Gothenburg
Research Site
Örebro
Research Site
Stockholm
About this study
Official title: Omeprazole Versus Anti-reflux Surgery in the Long-term Management of Peptic Esophagitis - a 10 Year Follow up Study of Patients Previously Studied for 5 Years - A Nordic Multicentre Study
The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment
- Conditions
- GERD
- Being tested
- Omeprazole
- Keywords
- Maintenance of healed erosive esophagitis
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of omeprazole during long term treatment
Secondary outcomes (1)
To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startJan 1998
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca GI Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256737
- Sponsor's protocol ID
- D9584C00004
- Other IDs
- SH OMG 0004
- Status last verified
- Jan 2011
- First submitted
- 20 Nov 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Publications
Attwood SE, Ell C, Galmiche JP, Fiocca R, Hatlebakk JG, Hasselgren B, Langstrom G, Jahreskog M, Eklund S, Lind T, Lundell L. Long-term safety of proton pump inhibitor therapy assessed under controlled, randomised clinical trial conditions: data from the SOPRAN and LOTUS studies. Aliment Pharmacol Ther. 2015 Jun;41(11):1162-74. doi: 10.1111/apt.13194. Epub 2015 Apr 10.
PubMed 25858519
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
- Omeprazole Versus Anti-reflux Surgery in the Long-term Management of Peptic Esophagitis - a 10 Year Follow up Study of Patients Previously Studied for 5 Years - A Nordic Multicentre Study
- ClinicalTrials.gov ID
- NCT00256737
- Acronym / sponsor ID
- D9584C00004
- Conditions
- GERD
- Keywords
- Maintenance of healed erosive esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 1998
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 22 Nov 2005 (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 purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (1 listed)
- Previous inclusion into Astra study I-635 and willing to continue for another 10 years,
Key exclusion criteria (1 listed)
- Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or confirmed malignancy; Documented eradication of Helicobacter pylori.
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 | Drug | – |
Primary outcome
Determine the safety of omeprazole during long term treatment
1 secondary outcome
To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole
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.
- Derived from this study: PubMed 25858519Attwood SE, Ell C, Galmiche JP, Fiocca R, Hatlebakk JG, Hasselgren B, Langstrom G, Jahreskog M, Eklund S, Lind T, Lundell L. Long-term safety of proton pump inhibitor therapy assessed under controlled, randomised clinical trial conditions: data from the SOPRAN and LOTUS studies. Aliment Pharmacol Ther. 2015 Jun;41(11):1162-74. doi: 10.1111/apt.13194. Epub 2015 Apr 10.
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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.
AstraZeneca GI Medical Science Director, MD study director
AstraZeneca
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omeprazole in people with GERD, run by AstraZeneca at 13 sites in 4 countries.
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 1 inclusion and 1 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.
Where is the study taking place?
The record lists 13 sites in Denmark, Norway, Sweden, Finland. 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?
Determine the safety of omeprazole during long term treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256737, which also lists 1 linked publication.
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.