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

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

Purpose

The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Indigestion Nausea and Vomiting Osteoarthritis Peptic Ulcer

Drug Information available for: Acetylsalicylic acid Naproxen Naproxen sodium Lansoprazole Celecoxib

U.S. FDA Resources

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
Experimental: Lansoprazole 30 mg QD + Naproxen 500 mg BID (and added aspirin)	Drug: Lansoprazole and 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.
Active Comparator: Celecoxib 200 mg QD (and added aspirin)	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 a non-steroidal anti-inflammatory drug 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

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

PREVACID® Package Insert This link exits the ClinicalTrials.gov site

Publications:

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:	Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00175032 History of Changes
Other Study ID Numbers:	LAN-0003-0041, U1111-1114-2275
Study First Received:	September 12, 2005
Last Updated:	July 20, 2010
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

Additional relevant MeSH terms:

Osteoarthritis
Peptic Ulcer
Ulcer
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Aspirin
Naproxen

Celecoxib
Lansoprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012