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

Purpose

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.

Condition	Intervention	Phase
Prevention	Drug: Esomeprazole Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Aspirin Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.

Enrollment:	427
Study Start Date:	February 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Esomeprazole 20mg Esomeprazole 20mg once daily oral	Drug: Esomeprazole 20mg, capsule, 72 weeks
Placebo Comparator: Placebo Placebo once daily oral	Drug: Placebo Placebo, capsule, 72 weeks

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069939

Show 46 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Kentaro Sugano, MD, PhD

Jichi Medical University

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01069939 History of Changes
Other Study ID Numbers:	D961PC00001
Study First Received:	February 16, 2010
Results First Received:	October 24, 2012
Last Updated:	October 24, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency Korea: Food and Drug Administration Taiwan: Department of Health

Keywords provided by AstraZeneca:

Gastric ulcer
Duodenal ulcer
Low-dose aspirin

Additional relevant MeSH terms:

Duodenal Ulcer
Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Aspirin
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013