NCT00256737

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_3

Geographic Reach
4 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

7.8 years

First QC Date

November 20, 2005

Last Update Submit

January 21, 2011

Conditions

GERD

Keywords

Maintenance of healed erosive esophagitis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

OmeprazoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or confirmed malignancy; Documented eradication of Helicobacter pylori.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Aalborg, Denmark

Location

Research Site

Glostrup Municipality, Denmark

Location

Research Site

Hillerød, Denmark

Location

Research Site

Kolding, Denmark

Location

Research Site

Odense, Denmark

Location

Research Site

Roskilde, Denmark

Location

Research Site

Kuopio, Finland

Location

Research Site

Bergen, Norway

Location

Research Site

Oslo, Norway

Location

Research Site

Trondheim, Norway

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Örebro, Sweden

Location

Research Site

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 25858519DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • AstraZeneca GI Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 20, 2005

First Posted

November 22, 2005

Study Start

January 1, 1998

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

SE(3)DK(6)FI(1)NO(3)