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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00542789

Purpose

The purpose of this study is to assess the efficacy of D961H 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

Condition	Intervention	Phase
Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago	Drug: Esomeprazole Drug: Placebo	Phase III

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Presence or absence of gastric and/or duodenal ulcer throughout the treatment period [ Time Frame: assessed at each visit up to 24 weeks ]

Secondary Outcome Measures:

Presence or absence of gastric and/or duodenal ulcers for up to 4 weeks and 12 weeks after initial administration, Severity of gastric mucosal lesion, Presence/absence and severity of NSAID-induced gastrointestinal symptoms, AEs, lab values, vital signs [ Time Frame: Assessed after 4, 12 and 24 weeks of treatment ]

Estimated Enrollment:	340
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Placebo once daily oral
2: Experimental Esomeprazole 20 mg	Drug: Esomeprazole 20mg once daily oral

Eligibility

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

Criteria

Inclusion Criteria:

Medical history of gastric and/or duodenal ulcer
A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion Criteria:

Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
History of esophageal, gastric or duodenal surgery
Having severe liver disease or chronic renal disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542789

Show 39 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Naotsugu Oyama

AstraZeneca Japan

More Information

Study ID Numbers:	D961HC00001
Study First Received:	October 11, 2007
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00542789
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

gastrointestinal
GI
NSAID
Japan

Japanese
Gastric ulcer
duodenal ulcer

Study placed in the following topic categories:

Stomach Ulcer
Autoimmune Diseases
Gastrointestinal Diseases
Osteoarthritis
Ulcer
Joint Diseases
Arthritis, Rheumatoid
Omeprazole
Low Back Pain
Rheumatic Diseases

Intestinal Diseases
Duodenal Ulcer
Stomach Diseases
Digestive System Diseases
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Duodenal Diseases
Peptic Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses

Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009