We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00595517
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : September 14, 2012
Last Update Posted : September 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago Drug: Esomeprazole 20 mg Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 395 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Esomeprazole 20 mg
Esomeprazole 20 mg once daily
Drug: Esomeprazole 20 mg
Esomeprazole 20 mg once daily


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period [ Time Frame: up to 52 weeks ]

Secondary Outcome Measures :
  1. Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment [ Time Frame: up to 4 weeks after treatment ]
  2. Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment [ Time Frame: up to 12 weeks after treatment ]
  3. Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment [ Time Frame: up to 24 weeks after treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 16, 2008    Key Record Dates
Results First Posted: September 14, 2012
Last Update Posted: September 14, 2012
Last Verified: August 2012

Keywords provided by AstraZeneca:
gastrointestinal
GI
NSAID
Japan
Japanese
Gastric ulcer
duodenal ulcer

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