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Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00595517
First received: January 7, 2008
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 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 20 mg
 Phase 3

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 (Esomeprazole) (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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment [ Time Frame: up to 4 weeks after treatment ] [ Designated as safety issue: No ]
  • Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment [ Time Frame: up to 12 weeks after treatment ] [ Designated as safety issue: No ]
  • Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment [ Time Frame: up to 24 weeks after treatment ] [ Designated as safety issue: No ]

Enrollment: 395
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esomeprazole 20 mg
Esomeprazole 20 mg once daily
 Drug: Esomeprazole 20 mg
Esomeprazole 20 mg once daily

  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 by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00595517     History of Changes
Other Study ID Numbers: D961HC00005
Study First Received: January 7, 2008
Results First Received: August 4, 2010
Last Updated: August 20, 2012
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 May 23, 2013