ClinicalTrials.gg
Sign In
CompletedNCT00259051Updated Jan 24, 2011

A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population

A Phase 3 interventional study of Omeprazole in Non-erosive Reflux Disease, sponsored by AstraZeneca. Completed at 13 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-01-24.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the pharmacodynamic effect of omeprazole n a Japanese non-erosive reflux disease population

02

Conditions studied

  • Non-erosive Reflux Disease
03

In context

Non-Erosive Reflux Disease

51 studies on the registry are indexed under Non-Erosive Reflux Disease; 7 are open to participants now.

This study's enrollment of 40 is below the median of 170 across 39 interventional studies indexed under Non-Erosive Reflux Disease.

Browse Non-Erosive Reflux Disease studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy. Written informed consent, ability to comply with study instructions

Exclusion criteria

Exclusion Criteria:

  • Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
40 participants

Interventions

06

What researchers measure

Primary outcomes

  1. To investigate the pharmacodynamic effect of omeprazole 10mg and 20mg od in patients with NERD, by assessment of the change of the percentage of time with intra-esophageal pH <4 during 24 hours.

Secondary outcomes

  1. To investigate the relation between pharmacodynamic effect and GERD symptoms,to investigate safety

07

Study locations

13 sites
  • Research Site
    Ashahikawa, Japan
  • Research Site
    Fukuoka, Japan
  • Research Site
    Hiroshima, Japan
  • Research Site
    Ichihara, Japan
  • Research Site
    Kochi, Japan
  • Research Site
    Koshigaya, Japan
  • Research Site
    Kurashiki, Japan
  • Research Site
    Nakano City, Japan
  • Research Site
    Nerima-ku, Japan
  • Research Site
    Osaka, Japan
  • Research Site
    Ōita, Japan
  • Research Site
    Sapporo, Japan
  • Research Site
    Yamato, Japan
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2004, a primary completion of Aug 2004 and a completion of Aug 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2005
First posted
Nov 29, 2005
Start
Jan 2004
Primary completionActual
Aug 2004
CompletionActual
Aug 2004
Last update
Jan 24, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00259051
Lead sponsor
AstraZeneca
Collaborators
Tanabe Pharma Corporation
First posted
Nov 29, 2005
Start date
Jan 2004
Primary completion
Aug 2004
Completion
Aug 2004
Last update
Jan 24, 2011

Study contacts

AstraZeneca Japan Medical Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Omeprazole

Other studies in this condition

Non-Erosive Reflux Disease →

Other studies from this sponsor

AstraZeneca →

Start the discussion