Sopran - Omeprazole Treatment Versus Surgery

NCT ID: NCT00256737

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2005-10-31

Brief Summary

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The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment

Detailed Description

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Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Omeprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previous inclusion into Astra study I-635 and willing to continue for another 10 years,

Exclusion Criteria

* Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or confirmed malignancy; Documented eradication of Helicobacter pylori.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca GI Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Aalborg, , Denmark

Site Status

Research Site

Glostrup Municipality, , Denmark

Site Status

Research Site

Hillerød, , Denmark

Site Status

Research Site

Kolding, , Denmark

Site Status

Research Site

Odense, , Denmark

Site Status

Research Site

Roskilde, , Denmark

Site Status

Research Site

Kuopio, , Finland

Site Status

Research Site

Bergen, , Norway

Site Status

Research Site

Oslo, , Norway

Site Status

Research Site

Trondheim, , Norway

Site Status

Research Site

Gothenburg, , Sweden

Site Status

Research Site

Örebro, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Countries

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Denmark Finland Norway Sweden

References

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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.

Reference Type DERIVED
PMID: 25858519 (View on PubMed)

Other Identifiers

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SH OMG 0004

Identifier Type: -

Identifier Source: secondary_id

D9584C00004

Identifier Type: -

Identifier Source: org_study_id

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