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

Refractory Reflux Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669811
• Other study ID #: D961UC00002
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2012
• Last updated: August 19, 2015
• Start date: August 2012
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and medical devices agency (PMDA)
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1398
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Refractory Reflux Esophagitis

Intervention

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
• 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

Locations

Country	Name	City	State
Japan	Research Site	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No
Secondary	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	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	No
Secondary	Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4	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	No
Secondary	Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4	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	No
Secondary	Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4	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	No
Secondary	Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4	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	No
Secondary	Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4	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	No

External Links

•   D961UC00002_Synopsis