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

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:

Genetics Home Reference related topics: rheumatoid arthritis

Drug Information available for: Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

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

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: 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
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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):

Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti-inflammatory drug-related peptic ulcers in Japanese patients. Aliment Pharmacol Ther. 2012 Jul;36(2):115-25. doi: 10.1111/j.1365-2036.2012.05133.x. Epub 2012 May 16.


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, Rheumatoid Duodenal 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 Esomeprazole Anti-Ulcer Agents Enzyme Inhibitors Gastrointestinal Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Proton Pump Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015