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A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00175032
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 22, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Peptic Ulcer Drug: Lansoprazole and naproxen and aspirin Drug: Celecoxib and aspirin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1045 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : July 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Gastroduodenal ulcers at final visit [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction) [ Time Frame: Week 12 ]
  2. Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores. [ Time Frame: Weeks 4,8, and 12 ]
  3. 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 ]
  4. Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline. [ Time Frame: Weeks 4, 8, and 12 ]
  5. Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia. [ Time Frame: Weeks 4, 8, and 12 ]
  6. The change from baseline SODA scale for subjects with dyspepsia at baseline. [ Time Frame: Weeks 4, 8, and 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00175032

Sponsors and Collaborators
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Study Director: Medical Director Takeda

Publications of Results:
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Responsible Party: Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc. Identifier: NCT00175032    
Other Study ID Numbers: LAN-0003-0041
U1111-1114-2275 ( Registry Identifier: WHO )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010
Keywords provided by Takeda:
Low dose aspirin
Peptic Ulcer
gastric ulcer
duodenal ulcer
Additional relevant MeSH terms:
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Peptic Ulcer
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors