Text Size

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00542789
First received: October 11, 2007
Last updated: May 10, 2010
Last verified: May 2010
History of Changes
  Purpose

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers


Condition Intervention Phase
Gastric Ulcer
Duodenal Ulcer
Rheumatoid Arthritis
Osteoarthritis
Lumbago
 Drug: Esomeprazole
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo 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:
  • Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period [ Time Frame: each visit up to 24 weeks ] [ Designated as safety issue: No ]
    The absence of gastric and/or duodenal ulcer throughout the treatment period


Secondary Outcome Measures:
  • Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
    The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment

  • Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment


Enrollment: 343
Study Start Date: August 2007
Study Completion Date: February 2009
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: Placebo
once daily oral
Experimental: 2
Esomeprazole 20 mg
 Drug: Esomeprazole
20mg once daily oral
Other Name: Nexium

  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: NCT00542789

Locations
Japan
Research Site
Chiryu, Aichi, Japan
Research Site
Seto, Aichi, Japan
Research Site
Yotukaido, Chiba, Japan
Research Site
Mizumaki, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, HYOGOi, Japan
Research Site
Itami, Hyogo, Japan
Research Site
Koto, Hyogo, Japan
Research Site
Nishinomiya, Hyogo, Japan
Research Site
Hitachi, Ibaragi, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Nagaokakyo, Kyoto, Japan
Research Site
Chiisagata, Nagano, Japan
Research Site
Matsumoto, Nagano, Japan
Research Site
Sasebo, Nagasaki, Japan
Research Site
Beppu, Oita, Japan
Research Site
Ihara, Okayama, Japan
Research Site
Hirakata, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Suita, Osaka, Japan
Research Site
Takatsuki, Osaka, Japan
Research Site
Kawagoe, Saitama, Japan
Research Site
Fukuroi, Shizuoka, Japan
Research Site
Hamamatsu, Shizuoka, Japan
Research Site
Izunokuni, Shizuoka, Japan
Research Site
Maikinohara, Shizuoka, Japan
Research Site
Yaizu, Shizuoka, Japan
Research Site
Shimotsuke, Tochigi, Japan
Research Site
Chiyoda, Tokyo, Japan
Research Site
Koto, Tokyo, Japan
Research Site
Musashimurayama, Tokyo, Japan
Research Site
Kyoto, Japan
Research Site
Nagano, Japan
Research Site
Oita, Japan
Research Site
Osaka, Japan
Research Site
Saitama, Japan
Research Site
Shizuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Naotsugu Oyama AstraZeneca Japan
  More Information

No publications provided by AstraZeneca

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

ClinicalTrials.gov Identifier: NCT00542789     History of Changes
Other Study ID Numbers: D961HC00001
Study First Received: October 11, 2007
Results First Received: February 16, 2010
Last Updated: May 10, 2010
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 19, 2013