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Completed

NCT Number: NCT00259051

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

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

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Key information

Conditions

Non-erosive Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Ashahikawa, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Omeprazole

Drug

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Tanabe Pharma Corporation

Registry information

Official study title

A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Investigate the Pharmacodynamic Effect by Assessment of the 24 Hours Intraesophageal pH Level, the Efficacy and Safety of Omeprazole 10mg and 20mg od in Patients With Non-erosive Reflux Disease (NERD).

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Nov 29, 2005
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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