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Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

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ClinicalTrials.gov Identifier: NCT01069939
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : November 22, 2012
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE February 16, 2010
First Posted Date  ICMJE February 17, 2010
Results First Submitted Date  ICMJE October 24, 2012
Results First Posted Date  ICMJE November 22, 2012
Last Update Posted Date November 22, 2012
Study Start Date  ICMJE February 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2012)
Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. [ Time Frame: From randomisation to up to 48 weeks (Maximum follow-up period at the 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2010)
Time from randomization to occurrence of gastric and/or duodenal ulcers [ Time Frame: Up to 12, 24, 36, 48, 60 and 72 weeks after randomisation ]
Change History Complete list of historical versions of study NCT01069939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2012)
  • Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
    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.
  • Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48. [ Time Frame: 12, 24, 36 and 48 weeks ]
    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.
  • Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
    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".
  • Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48. [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
    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".
  • Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
    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".
  • Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
    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".
  • Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
    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".
  • Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
    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".
  • Number of Participants With Adverse Events [ Time Frame: Up to 70 weeks at the longest ]
    Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2010)
  • Degree of gastric mucosal lesion by modified LANZA score. Presence/absence and severity of RE evaluated by the LA classification [ Time Frame: Up to 12, 24, 36, 48, 60 and 72 weeks after randomisation ]
  • Presence/absence and severity of gastrointestinal symptoms assessed by the investigator(s) at each visit [ Time Frame: Every 4 weeks up to 72 weeks after dandomization ]
  • Adverse events, Clinical laboratory values, Vital signs [ Time Frame: Every 4 weeks up to 72 weeks after dandomization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
Official Title  ICMJE A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Prevention
Intervention  ICMJE
  • Drug: Esomeprazole
    20mg, capsule, 72 weeks
  • Drug: Placebo
    Placebo, capsule, 72 weeks
Study Arms  ICMJE
  • Experimental: Esomeprazole 20mg
    Esomeprazole 20mg once daily oral
    Intervention: Drug: Esomeprazole
  • Placebo Comparator: Placebo
    Placebo once daily oral
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2012)
427
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2010)
426
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of written informed consent before starting the study-related procedures and examinations
  • Patients who have the history of gastric and/or duodenal ulcer.
  • A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.

Exclusion Criteria:

  • Having gastric or duodenal ulcer (except for ulcer scar).
  • History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01069939
Other Study ID Numbers  ICMJE D961PC00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kentaro Sugano, MD, PhD Jichi Medical University
PRS Account AstraZeneca
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP