A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00175032

Purpose

The objective of this study is to compare the gastroduodenal ulceration rate, and gastrointestinal (GI) complication rate and non-steroidal anti-inflammatory drug (NSAID)-associated dyspepsia between lansoprazole 30 mg QD and naproxen 500 mg BID and celecoxib 200 mg QD in osteoarthritis (OA) subjects taking low dose aspirin at the end of the 12 weeks of treatment.

Condition	Intervention	Phase
Osteoarthritis Peptic Ulcer	Drug: Lansoprazole, Naproxen and aspirin Drug: Celecoxib and aspirin	Phase III

MedlinePlus related topics: Indigestion Nausea and Vomiting Osteoarthritis Peptic Ulcer

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Naproxen Naproxen sodium Acetylsalicylic acid Lansoprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of Lansoprazole 30 mg QD and Naproxen 500 mg BID Versus Celecoxib 200 mg QD in Risk Reduction of Non Steroidal Anti-Inflammatory-Associated Ulcers in Osteoarthritis Subjects Taking Low Dose Aspirin

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Gastroduodenal ulcers at final visit [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores. [ Time Frame: Weeks 4,8, and 12 ] [ Designated as safety issue: No ]
Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline. [ Time Frame: Weeks 4,8, and 12 ] [ Designated as safety issue: No ]
Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline. [ Time Frame: Weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia. [ Time Frame: Weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
The change from baseline SODA scale for subjects with dyspepsia at baseline. [ Time Frame: Weeks 4, 8, and 12 ] [ Designated as safety issue: No ]

Enrollment:	1045
Study Start Date:	July 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lansoprazole, Naproxen and aspirin Lansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
2: Active Comparator	Drug: Celecoxib and aspirin Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.

Detailed Description:

This study was designed to compare the effectiveness of reducing the incidence of gastroduodenal ulcers between lansoprazole 30mg QD + naproxen 500mg BID vs celecoxib 200mg QD in subjects with osteoarthritis taking low dose aspirin. Approximately 100 sites across the U.S. will enroll subjects with normal endoscopic findings and negative H.pylori. The duration of the study will be a maximum of 14 weeks including a screening period of up to 2 weeks and a 12 week treatment period. Gelusil will be provided for dyspepsia symptom rescue.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must require the chronic use of an NSAID for the treatment of osteoarthritis.
Must be taking daily aspirin for cardiovascular prophylaxis.
Clinical Laboratory values within normal limits for this population

Exclusion Criteria:

History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
Evidence of uncontrolled, clinically significant disease.
History of cancer within the past 5 years.
Presence of gastroduodenal ulcers, esophageal ulcer or >= 10 gastroduodenal erosions during the screening endoscopy. Known history of gastroduodenal ulcer or bleeding within the past year. Esophageal stricture requiring dilatation.
Presence of Barrett's esophagus with dysplastic changes.
Systemic disease affecting the esophagus or a history of caustic or physiochemical trauma or irradiation to the esophagus.
Sero-tests positive for H. pylori.
Evidence of Zollinger-Ellison syndrome, esophageal varices, cholecystitis, or pancreaticobiliary tract disease.
Requires treatment with an excluded medication such as proton pump inhibitors, histamine H2 receptor antagonists, antacids, corticosteroids, lithium, fluconazole, misoprostol, probenecid, methotrexate, anticoagulants, St. John's wart, dong quai, feverfew, garlic, ginger, horse chestnut, red clover or white willow supplements or bisphosphonates.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175032

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

For Trial Results, refer to this link: This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls, refer to this link: This link exits the ClinicalTrials.gov site

For the Prevacid Package Insert, refer to this link: This link exits the ClinicalTrials.gov site

Publications of Results:

Goldstein JL, Cryer B, Amer F, Hunt B. Celecoxib plus aspirin versus naproxen and lansoprazole plus aspirin: a randomized, double-blind, endoscopic trial. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1167-74.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences )
Study ID Numbers:	LAN-0003-0041
Study First Received:	September 12, 2005
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00175032
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Low dose aspirin
Peptic Ulcer
gastric ulcer
duodenal ulcer
NSAIDs

Study placed in the following topic categories:

Stomach Ulcer
Naproxen
Celecoxib
Osteoarthritis
Gastrointestinal Diseases
Ulcer
Joint Diseases
Rheumatic Diseases
Intestinal Diseases

Duodenal Ulcer
Stomach Diseases
Digestive System Diseases
Aspirin
Musculoskeletal Diseases
Arthritis
Lansoprazole
Peptic Ulcer
Duodenal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Gout Suppressants
Pharmacologic Actions

Fibrin Modulating Agents
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009