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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D961H 20mg twice daily | Experimental | Double-blinded |
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| D961H 20mg once daily | Active Comparator | Double-blinded |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole (D961H) twice daily | Drug | One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening |
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| 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 | 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 |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tore Lind, MSD | AstraZeneca, Moelndal, Sweden | Study Director |
| Lan Chen | AstraZeneca, Osaka, Japan | Study Director |
| Yoshikazu Kinoshita, PROFESSOR OF MEDICINE | Dept of Gastroenterology and Hepatology, Shimane, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Abiko-shi | Japan | ||||
| Research Site |
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| Label | URL |
|---|---|
| D961UC00002\_Synopsis | View source |
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Out of 1398 enrolled subjects, 287 subjects were randomised and 1111 subjects were not randomised. The reasons of no randomisation were 'Eligibilty criteria not met' (1067 subjects), 'Subject decision' (37 subjects), 'Adverse event' (2 subjects) and other reasons (5 subjects).
First subject enrolled on 25 August 2012. Last subject completed on 30 May 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | D961H 20 mg BID | Hard capsule containing 22.3 mg of D961H as enteric coated pellets |
| FG001 | D961H 20 mg QD + Placebo | Hard capsule unidentifiable to D961H capsule 20 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Esomeprazole (D961H) once daily | Drug | 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 |
|
| 4 Weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | Bunkyō City | Japan |
| Research Site | Chūōku | Japan |
| Research Site | Fujiidera-shi | Japan |
| Research Site | Fukuoka | Japan |
| Research Site | Fukushima | Japan |
| Research Site | Gifu | Japan |
| Research Site | Hamamatsu | 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 | Japan |
| Research Site | Kamakura-shi | Japan |
| Research Site | Kanazawa | Japan |
| Research Site | Karatsu-shi | Japan |
| Research Site | Kawasaki-shi | Japan |
| Research Site | Kirishima-shi | Japan |
| Research Site | Kita-ku | Japan |
| Research Site | Kobe | Japan |
| Research Site | Kochi | Japan |
| Research Site | Koga-shi | Japan |
| Research Site | Koriyama-shi | Japan |
| Research Site | Kumagaya-shi | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Kyoto | 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 | Okayama | Japan |
| Research Site | Osaka | Japan |
| Research Site | Otawara-shi | Japan |
| Research Site | Ōita | Japan |
| Research Site | Ōta-ku | Japan |
| Research Site | Saga | Japan |
| Research Site | Saitama-shi | Japan |
| Research Site | Sakaide-shi | Japan |
| Research Site | Sakushu | Japan |
| Research Site | Sapporo | Japan |
| Research Site | Sendai | 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 | Japan |
| Research Site | Uji-shi | Japan |
| Research Site | Wakayama | Japan |
| Research Site | Yanagawa-shi | Japan |
| Research Site | Yokohama | Japan |
| Research Site | Yufu-shi | Japan |
| COMPLETED |
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| NOT COMPLETED |
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It was found that 2 patients in D961H 20 mg QD + Placebo group had no refractory RE after randomisation. Therefore, these two patients were excluded from the full analysis set, which was the primary analysis set of this study and was used for summaries of baseline characteristics and outcome measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | D961H 20 mg BID | D961H 20 mg twice Daily |
| BG001 | D961H 20 mg QD + Placebo | D961H 20 mg once daily along with placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product | Posted | Number | 95% Confidence Interval | Percentage of participants | 8 Weeks |
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| 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 | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product | Posted | Number | 95% Confidence Interval | Percentage of participants | 4 Weeks |
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| 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. | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -heartburn at baseline were included. | Posted | Number | Percentage of participants | 4 Weeks |
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| 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. | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -acid regurgitation at baseline were included. | Posted | Number | Percentage of participants | 4 Weeks |
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| 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. | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -abdominal pain at baseline were included. | Posted | Number | Percentage of participants | 4 Weeks |
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| 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. | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -difficulty of swallowing at baseline were included. | Posted | Number | Percentage of participants | 4 Weeks |
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| 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. | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -sleep disturbance at baseline were included. | Posted | Number | Percentage of participants | 4 Weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D961H 20 mg BID | D961H 20 mg twice Daily | 1 | 145 | 8 | 145 | ||
| EG001 | D961H 20 mg QD + Placebo | D961H 20 mg once daily along with placebo | 3 | 142 | 9 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Parotid abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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All PIs were prohibited to disclose all information related to this study withiout AZ approval before this study was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masahiro Nii | Clinical Statistics & Programming Department, Clinical Science Division, R&D, AstraZeneca Japan | Masahiro.Nii@astrazeneca.com |
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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