Long Term Study to Investigate the Efficacy & Safety of D961H for the Prevention of NSAIDs-Induced Ulcer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00595517

Purpose

The purpose of this study is to assess the Safety and tolerability of D961H 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Condition	Intervention	Phase
Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago	Drug: esomeprazole, 20mg	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, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) 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:

To asess the safety & tolerability of D961H 20mg by evaluating AEs, clinical laboratory value and vital signs.

Secondary Outcome Measures:

Presence or absence of gastric and/or duodenal ulcers at 4, 12, 24 and 52 weeks. Severity of gastric mucosal lesion evaluated by LANZA score. Presence/absence and severity of NSAID-induced gastrointestinal symptoms

Estimated Enrollment:	130
Study Start Date:	October 2007

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: NCT00595517

Locations

Japan
Research Site
Oita, Japan
Research Site
Tokyo, Japan
Research Site
Saitama, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Naotsugu Oyama

AstraZeneca

More Information

Study ID Numbers:	D961HC00005
Study First Received:	January 7, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00595517
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 16, 2009