Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus) - Full Text View

Purpose

This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification

Condition	Intervention	Phase
Refractory Reflux Esophagitis	Drug: Esomeprazole (D961H) twice daily Drug: Esomeprazole (D961H) once daily	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The proportion of subjects with healed Reflux Esophagitis (healing rate of RE) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects with healed Reflux Esophagitis (healing rate of RE) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The presence/absence of the patient-reported gastroesophageal reflux disease (GERD) symptoms according to Patient Diary [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Severity of the patient-reported gastroesophageal reflux disease (GERD) symptoms according to Patient Diary. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	August 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: D961H 20mg twice daily Double-blinded	Drug: Esomeprazole (D961H) twice daily One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening
Active Comparator: D961H 20mg once daily Double-blinded	Drug: Esomeprazole (D961H) once daily One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening

Detailed Description:

A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs.
Patients must fulfill at least one of the following criteria such as (i) RE with LA grade C/D at Endoscopy on visit 1 and/or history of RE with LA grade C/D, (ii) RE was diagnosed more than 1 year before visit 1.
Patients who are able to complete the Patient Diary

Exclusion Criteria:

Male or female aged less than 20 years at the time of informed consent.
Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc
Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation.
Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc
Current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669811

Contacts

Contact: Iwami Nakatani

+81-6-6453-7442

I.Nakatani@astrazeneca.com

Locations

Japan
Research Site	Not yet recruiting
Chiba, Japan
Research Site	Not yet recruiting
Fukuoka, Japan
Research Site	Not yet recruiting
Fukushima, Japan
Research Site	Not yet recruiting
Gifu, Japan
Research Site	Recruiting
Gunma, Japan
Principal Investigator: Satoshi Ono
Research Site	Not yet recruiting
Hokkaido, Japan
Research Site	Not yet recruiting
Hyogo, Japan
Research Site	Not yet recruiting
Ibaraki, Japan
Research Site	Not yet recruiting
Kagoshima, Japan
Research Site	Not yet recruiting
Kanagawa, Japan
Research Site	Not yet recruiting
Kyoto, Japan
Research Site	Not yet recruiting
Nagano, Japan
Research Site	Not yet recruiting
Oita, Japan
Research Site	Not yet recruiting
Okayama, Japan
Research Site	Not yet recruiting
Osaka, Japan
Research Site	Not yet recruiting
Osaka-shi, Japan
Research Site	Not yet recruiting
Saga, Japan
Research Site	Not yet recruiting
Saitama, Japan
Research Site	Not yet recruiting
Tochigi, Japan
Research Site	Not yet recruiting
Tokyo, Japan
Research Site	Not yet recruiting
Wakayama, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tore Lind, MSD	AstraZeneca, Moelndal, Sweden
Study Director:	Yuji Hoshino, STUDY PHYSICIAN	AstraZeneca, Osaka, Japan
Principal Investigator:	Yoshikazu Kinoshita, PROFESSOR OF MEDICINE	Dept of Gastroenterology and Hepatology, Shimane, Japan

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01669811 History of Changes
Other Study ID Numbers:	D961UC00002
Study First Received:	August 17, 2012
Last Updated:	August 31, 2012
Health Authority:	Japan: Pharmaceuticals and medical devices agency (PMDA)

Keywords provided by AstraZeneca:

Refractory Reflux Esophagitis,
Japanese,
Nexium,
twice daily,
oral administration

Additional relevant MeSH terms:

Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Esophageal Motility Disorders

Deglutition Disorders
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013