FindTrial
Sign In

A Double-Blind, Randomised, Parallel-Group, Multicentre, Phase III Study to Investigate the Pharmacodynamic Effect by Assessment of the 24 Hours Intra-esophageal pH Level, the Efficacy and Safety of Omeprazole 10mg and 20mg Od in Patients with Non-Erosive Reflux Disease (NERD)

A Double-Blind, Randomised, Parallel-Group, Multicentre, Phase III Study to Investigate the Pharmacodynamic Effect by Assessment of the 24 Hours Intra-esophageal pH Level, the Efficacy and Safety of Omeprazole 10mg and 20mg Od in Patients with Non-Erosive Reflux Disease (NERD)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220396
Enrollment
Unknown
Registered
2007-05-24
Start date
2007-05-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Erosive Reflux Disease

Interventions

investigational material(s) Generic name etc : Omeprazole INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational mater

Sponsors

AstraZeneca/Mitsubishi Tanabe Pharma Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria: -Patients who identified their predominant symptom as heartburn and were classified as Grade M or N according to Hoshihara's modified version of Los Angeles Classification at esophagogastroduodenoscopy. Exclusion Criteria: -Patients with any ongoing gastrointestinal bleeding at the time of esophagogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concomitant drugs likely to interfere with the evaluation of this study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy Primary Outcomes: 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: To investigate the relation between pharmacodynamic effect and GERD symptoms, to investigate safety.—

Contacts

Public Contact; ;

AstraZeneca;Mitsubishi Tanabe Pharma Corporation

;;

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026