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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):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 7, 2008
First Posted Date  ICMJE January 16, 2008
Results First Submitted Date  ICMJE August 4, 2010
Results First Posted Date  ICMJE September 14, 2012
Last Update Posted Date September 14, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period [ Time Frame: up to 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
To asess the safety & tolerability of D961H 20mg by evaluating AEs, clinical laboratory value and vital signs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
  • Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment [ Time Frame: up to 4 weeks after treatment ]
  • Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment [ Time Frame: up to 12 weeks after treatment ]
  • Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment [ Time Frame: up to 24 weeks after treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Gastric Ulcer
  • Duodenal Ulcer
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Lumbago
Intervention  ICMJE Drug: Esomeprazole 20 mg
Esomeprazole 20 mg once daily
Study Arms  ICMJE Experimental: Esomeprazole 20 mg
Esomeprazole 20 mg once daily
Intervention: Drug: Esomeprazole 20 mg
Publications * Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs. BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2012)
395
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2008)
130
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00595517
Other Study ID Numbers  ICMJE D961HC00005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Naotsugu Oyama AstraZeneca
PRS Account AstraZeneca
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP