Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole 20mg | Experimental | Esomeprazole 20mg once daily oral |
|
| Placebo | Placebo Comparator | Placebo once daily oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 20mg, capsule, 72 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. | Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks. | From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48 | Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kentaro Sugano, MD, PhD | Jichi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Yotsukaidou | Chiba | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24326741 | Derived | Sugano K, Choi MG, Lin JT, Goto S, Okada Y, Kinoshita Y, Miwa H, Chiang CE, Chiba T, Hori M, Fukushima Y, Kim HS, Chang CY, Date M; LAVENDER Study Group. Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study. Gut. 2014 Jul;63(7):1061-8. doi: 10.1136/gutjnl-2013-304722. Epub 2013 Dec 10. |
Not provided
Not provided
Out of 914 enrolled participants, 430 participants were assigned , but 484 participants were not assigned. The major reasons of no assignment were 'Did not meet eligibility criteria' (462 participants) and 'Voluntary discontinuation by participant' (21 participants). After 366 participants were randomised, the interim analysis was done.
First participant enrolled on 4 February 2010. On 20 May 2011, the efficacy analysis was completed based on positive results of an interim analysis so that the efficacy data in this report are at the interim analysis. To evaluate the safety, the study was continued. The last participant completed the study on 9 November 2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole 20mg | Esomeprazole 20mg once daily oral |
| FG001 | Placebo | Placebo once daily oral |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomised and Included in the Analyses |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo, capsule, 72 weeks |
|
| Up to 48 weeks (Baseline to last measurement) |
| Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48. | Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not. | 12, 24, 36 and 48 weeks |
| Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48 | The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Up to 48 weeks (Baseline to last measurement) |
| Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48. | The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Up to 48 weeks (Baseline to last measurement) |
| Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48 | The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Up to 48 weeks (Baseline to last measurement) |
| Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week | The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Up to 48 weeks (Baseline to last measurement) |
| Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48 | The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Up to 48 weeks (Baseline to last measurement) |
| Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48 | The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Up to 48 weeks (Baseline to last measurement) |
| Number of Participants With Adverse Events | Participants who had at least adverse events (AE) which occurred after receiving study drug were counted. | Up to 70 weeks at the longest |
| Fukui-shi |
| Fukui |
| Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Kitakyushu-Shi | Fukuoka | Japan |
| Research Site | Onga-Gun | Fukuoka | Japan |
| Research Site | Yukuhashi | Fukuoka | Japan |
| Research Site | Fukushima | Fukushima | Japan |
| Research Site | Kōriyama | Fukushima | Japan |
| Research Site | Nihommatsu | Fukushima | Japan |
| Research Site | Fukuyama | Hiroshima | Japan |
| Research Site | Kure | Hiroshima | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Amagasaki | Hyōgo | Japan |
| Research Site | Itami | Hyōgo | Japan |
| Research Site | Kobe | Hyōgo | Japan |
| Research Site | Nishinomiya | Hyōgo | Japan |
| Research Site | Higashi-ibaraki, | Ibaraki | Japan |
| Research Site | Komatsu | Ishikawa-ken | Japan |
| Research Site | Nomi | Ishikawa-ken | Japan |
| Research Site | Kawasaki-shi | Kanagawa | Japan |
| Research Site | Yokohama | Kanagawa | Japan |
| Research Site | Uji | Kyoto | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Daitō | Osaka | Japan |
| Research Site | Kishiwada | Osaka | Japan |
| Research Site | Matsubara | Osaka | Japan |
| Research Site | Minato | Osaka | Japan |
| Research Site | Yao | Osaka | Japan |
| Research Site | Hanyū | Saitama | Japan |
| Research Site | Shizuoka | Shizuoka | Japan |
| Research Site | Shimotsuke | Tochigi | Japan |
| Research Site | Chūō | Tokyo | Japan |
| Research Site | Minato | Tokyo | Japan |
| Research Site | Shinagawa | Tokyo | Japan |
| Research Site | Shinjuku | Tokyo | Japan |
| Research Site | Shimonoseki | Yamaguchi | Japan |
| Research Site | Gangneung | Gangwon-do | South Korea |
| Research Site | Wŏnju | Gangwon-do | South Korea |
| Research Site | Seongnam-si | Gyeonggi-do | South Korea |
| Research Site | Busan | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Niao-Song-Shiang | Kaohsiung | Taiwan |
| Research Site | Kweishan Shiang | Taoyuan Hsien | Taiwan |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | Tainan | Taiwan |
| Research Site | Taipei | Taiwan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| At Data Cut Off Date (26 Feb 2011) |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole 20mg | Esomeprazole 20mg once daily oral |
| BG001 | Placebo | Placebo once daily oral |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | Participants |
| |||||||||||||||||||
| Helicobacter pylori status | 8 participants had a missing for this measurement (3 participants in Esomeprazole 20 mg group and 5 participants in Placebo group). Negative means a patient had no Helicobacter pylori infection and Positive means a patient had Helicobacter pylori infection. | Number | Participants |
|
| 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 | Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. | Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks. | Participants not taking investigational drug were not included. In total 364 participants were included in the efficacy evaluation at the interim analysis. 24 of the 364 total participants had an occurrence of gastric and/or duodenal ulcers by the 48-week assessment. | Posted | Number | Participants | From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48 | Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion. | Participants who had LANZA scores at both baseline and post-dose were included into this analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Up to 48 weeks (Baseline to last measurement) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48. | Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not. | Patients with endoscopy were included in the analyses at 12, 24, 36 and 48 weeks after randomisation. | Posted | Number | Participants | 12, 24, 36 and 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48 | The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Participants who had the measurements of epigastric pain at baseline and post-dose up to 48 weeks were included in this analysis. | Posted | Number | Participants | Up to 48 weeks (Baseline to last measurement) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48. | The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Participants who had the measurements of heartburn at baseline and post-dose up to 48 weeks were included in this analysis. | Posted | Number | Participants | Up to 48 weeks (Baseline to last measurement) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48 | The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Participants who had the measurements of anorexia at baseline and post-dose up to 48 weeks were included in this analysis. | Posted | Number | Participants | Up to 48 weeks (Baseline to last measurement) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week | The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Participants who had the measurements of abdomen enlarged feeling at baseline and post-dose up to 48 weeks were included in this analysis. | Posted | Number | Participants | Up to 48 weeks (Baseline to last measurement) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48 | The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Participants who had the measurements of Nausea and/or Vomiting at baseline and post-dose up to 48 weeks were included in this analysis. | Posted | Number | Participants | Up to 48 weeks (Baseline to last measurement) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48 | The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into "Improved". If the value was same, categorised into "Unchanged". If the value was worsened, categorise into "Worsened". | Posted | Number | Participants | Up to 48 weeks (Baseline to last measurement) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Participants who had at least adverse events (AE) which occurred after receiving study drug were counted. | All participants who received any study drug were included in this analysis. | Posted | Number | Participants | Up to 70 weeks at the longest |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esomeprazole 20mg | Esomeprazole 20mg once daily oral | 17 | 214 | 70 | 214 | ||
| EG001 | Placebo | Placebo once daily oral | 15 | 213 | 53 | 213 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cholecystectomy | Surgical and medical procedures | Systematic Assessment |
| ||
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epididymitis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Renal Infarct | Renal and urinary disorders | Systematic Assessment |
| ||
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Prostatic Specific Antigen Increased | Investigations | Systematic Assessment |
| ||
| Hip Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| In-Stent Coronary Artery Restenosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infective Exacerbation Of Chronic Obstructive Airways Disease | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Cholangitis Acute | Hepatobiliary disorders | Systematic Assessment |
| ||
| Gastritis Erosive | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diverticulum Intestinal Haemorrhagic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cardiac Myxoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Malignant Ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Epilepsy | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral Infarction | Nervous system disorders | Systematic Assessment |
| ||
| Brain Stem Haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Arteriosclerosis Coronary Artery | Cardiac disorders | Systematic Assessment |
| ||
| Angina Pectoris | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric Polyps | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| D004381 | Duodenal Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >=75 years |
|
| Male |
|
| Japan |
|
| Korea, Republic of |
|
| Negative |
|
| 25 - 36 weeks |
|
| 37 - 48 weeks |
|
|
|
|
|
|
|
|
|
|