Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-Induced Gastric Ulcer

This study has been completed.

First Received: November 17, 2006 Last Updated: March 11, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00401752

Purpose

The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy.

Condition	Intervention	Phase
Gastric Ulcer	Drug: Esomeprazole Drug: Ranitidine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, 8 Week Comparative Efficacy and Safety Study of Esomeprazole 20 mg qd Versus Ranitidine 150 mg Bid in Patients With an NSAID-Associated Gastric Ulcer When Daily NSAID is Continued

Resource links provided by NLM:

Drug Information available for: Ranitidine Ranitidine Hydrochloride Omeprazole Omeprazole magnesium Ranitidine bismuth citrate Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Assess the efficacy of esomeprazole 20 mg qd through 4 weeks of treatment in these patients

Secondary Outcome Measures:

Assess the efficacy of esomeprazole 20 mg qd through 8 weeks of treatment in these patients.
Evaluate the patient symptoms for up to 8 weeks of treatment in these patients.
Evaluate the safety and tolerability for up to 8 weeks of treatment in these patients.

Estimated Enrollment:	320
Study Start Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent.
A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 2 months.
Daily NSAID dose and type must have been stable for at least 2 weeks prior to the baseline endoscopy;orally;

Exclusion Criteria:

History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401752

Locations

China
Research Site
Shanghai, China
Research Site
Beijing, China
China, Fujian
Research Site
Fuzhou, Fujian, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Jiangsu
Research Site
Suzhou, Jiangsu, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shanxi
Research Site
Xi'an, Shanxi, China
Hong Kong
Research Site
Hong Kong, Hong Kong

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Tore Lind, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D9617L00001
Study First Received:	November 17, 2006
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00401752 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by AstraZeneca:

NSAID-associated gastric ulcer

Study placed in the following topic categories:

Stomach Ulcer
Anti-Inflammatory Agents
Neurotransmitter Agents
Bismuth tripotassium dicitrate
Gastrointestinal Diseases
Ulcer
Citric Acid
Omeprazole
Histamine H2 Antagonists
Histamine
Bismuth
Ranitidine

Digestive System Diseases
Stomach Diseases
Histamine Antagonists
Ranitidine bismuth citrate
Analgesics, Non-Narcotic
Citrate
Histamine phosphate
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Peptic Ulcer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Omeprazole
Pathologic Processes
Stomach Diseases
Ranitidine bismuth citrate
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Peptic Ulcer
Stomach Ulcer
Ulcer
Gastrointestinal Agents
Histamine Agents
Enzyme Inhibitors
Pharmacologic Actions
Histamine H2 Antagonists
Ranitidine
Digestive System Diseases
Histamine Antagonists
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 03, 2009