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

August 19, 2015 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1398

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Abiko-shi, Japan
        • Research Site
      • Adachi-ku, Japan
        • Research Site
      • Annaka-shi, Japan
        • Research Site
      • Asahikawa-shi, Japan
        • Research Site
      • Asakura-shi, Japan
        • Research Site
      • Beppu-shi, Japan
        • Research Site
      • Bunkyo-ku, Japan
        • Research Site
      • Chuo-ku, Japan
        • Research Site
      • Fujiidera-shi, Japan
        • Research Site
      • Fukuoka-shi, Japan
        • Research Site
      • Fukushima-shi, Japan
        • Research Site
      • Gifu-shi, Japan
        • Research Site
      • Hamamatsu-shi, Japan
        • Research Site
      • Hirakata-shi, Japan
        • Research Site
      • Hitachi-shi, Japan
        • Research Site
      • Ibara-shi, Japan
        • Research Site
      • Ichiki-Kushikino-shi, Japan
        • Research Site
      • Ishikari-shi, Japan
        • Research Site
      • Iwata-shi, Japan
        • Research Site
      • Izumo-shi, Japan
        • Research Site
      • Kagoshima-shi, Japan
        • Research Site
      • Kamakura-shi, Japan
        • Research Site
      • Kanazawa-shi, Japan
        • Research Site
      • Karatsu-shi, Japan
        • Research Site
      • Kawasaki-shi, Japan
        • Research Site
      • Kirishima-shi, Japan
        • Research Site
      • Kita-ku, Japan
        • Research Site
      • Kobe-shi, Japan
        • Research Site
      • Kochi-shi, Japan
        • Research Site
      • Koga-shi, Japan
        • Research Site
      • Koriyama-shi, Japan
        • Research Site
      • Kumagaya-shi, Japan
        • Research Site
      • Kumamoto-shi, Japan
        • Research Site
      • Kyoto-shi, Japan
        • Research Site
      • Machida-shi, Japan
        • Research Site
      • Matsumoto-shi, Japan
        • Research Site
      • Meguro-ku, Japan
        • Research Site
      • Moriguchi-shi, Japan
        • Research Site
      • Nishinomiya-shi, Japan
        • Research Site
      • Ogori-shi, Japan
        • Research Site
      • Oita-shi, Japan
        • Research Site
      • Okayama-shi, Japan
        • Research Site
      • Osaka-shi, Japan
        • Research Site
      • Ota-ku, Japan
        • Research Site
      • Otawara-shi, Japan
        • Research Site
      • Saga-shi, Japan
        • Research Site
      • Saitama-shi, Japan
        • Research Site
      • Sakaide-shi, Japan
        • Research Site
      • Saku-shi, Japan
        • Research Site
      • Sapporo-shi, Japan
        • Research Site
      • Sendai-shi, Japan
        • Research Site
      • Shibuya-ku, Japan
        • Research Site
      • Shinagawa-ku, Japan
        • Research Site
      • Shinjuku-ku, Japan
        • Research Site
      • Takasaki-shi, Japan
        • Research Site
      • Takatsuki-shi, Japan
        • Research Site
      • Toshima-ku, Japan
        • Research Site
      • Toyama-shi, Japan
        • Research Site
      • Uji-shi, Japan
        • Research Site
      • Wakayama-shi, Japan
        • Research Site
      • Yanagawa-shi, Japan
        • Research Site
      • Yokohama-shi, Japan
        • Research Site
      • Yufu-shi, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures.
  2. 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.
  3. 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.
  4. Patients who are able to complete the Patient Diary

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
Time Frame: 8 Weeks
Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 8 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Healing of RE Who Were Graded "O" at Week 4 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
Time Frame: 4 Weeks
Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 4 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4
Time Frame: 4 Weeks
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method.
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4
Time Frame: 4 Weeks
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method.
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4
Time Frame: 4 Weeks
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method.
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4
Time Frame: 4 Weeks
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method.
4 Weeks
Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4
Time Frame: 4 Weeks
Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method.
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Tore Lind, MSD, AstraZeneca, Moelndal, Sweden
  • Study Director: Lan Chen, AstraZeneca, Osaka, Japan
  • Principal Investigator: Yoshikazu Kinoshita, PROFESSOR OF MEDICINE, Dept of Gastroenterology and Hepatology, Shimane, Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 17, 2012

First Posted (Estimate)

August 21, 2012

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961UC00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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