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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Rheumatoid
Duodenal Ulcer
Osteoarthritis
Stomach Ulcer
Ulcer
Arthritis
Autoimmune Diseases
Connective Tissue Diseases
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Immune System Diseases
Intestinal Diseases
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Peptic Ulcer
Rheumatic Diseases
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Esomeprazole
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Ulcer Agents
Antirheumatic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 20, 2014