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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

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

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess 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:	340
Study Start Date:	October 2007
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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
Saitama, Japan
Research Site
Tokyo, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Naotsugu Oyama

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00595517 History of Changes
Other Study ID Numbers:	D961HC00005
Study First Received:	January 7, 2008
Last Updated:	September 10, 2009
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

gastrointestinal
GI
NSAID
Japan

Japanese
Gastric ulcer
duodenal ulcer

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Duodenal Ulcer
Osteoarthritis
Stomach Ulcer
Ulcer
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases

Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012