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

Primary Purpose

Osteoarthritis, Peptic Ulcer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lansoprazole and naproxen and aspirin
Celecoxib and aspirin
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Low dose aspirin, Peptic Ulcer, gastric ulcer, duodenal ulcer, NSAIDs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lansoprazole 30 mg QD + Naproxen 500 mg BID

    Celecoxib 200 mg QD

    Arm Description

    (and added aspirin)

    (and added aspirin)

    Outcomes

    Primary Outcome Measures

    Gastroduodenal ulcers at final visit

    Secondary Outcome Measures

    Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction)
    Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores.
    Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline.
    Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline.
    Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia.
    The change from baseline SODA scale for subjects with dyspepsia at baseline.

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    July 20, 2010
    Sponsor
    Takeda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00175032
    Brief Title
    A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    July 2004 (Actual)
    Study Completion Date
    July 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Takeda

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Peptic Ulcer
    Keywords
    Low dose aspirin, Peptic Ulcer, gastric ulcer, duodenal ulcer, NSAIDs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1045 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lansoprazole 30 mg QD + Naproxen 500 mg BID
    Arm Type
    Experimental
    Arm Description
    (and added aspirin)
    Arm Title
    Celecoxib 200 mg QD
    Arm Type
    Active Comparator
    Arm Description
    (and added aspirin)
    Intervention Type
    Drug
    Intervention Name(s)
    Lansoprazole and naproxen and aspirin
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Celecoxib and aspirin
    Intervention Description
    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 Measure Information:
    Title
    Gastroduodenal ulcers at final visit
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction)
    Time Frame
    Week 12
    Title
    Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores.
    Time Frame
    Weeks 4,8, and 12
    Title
    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
    Title
    Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline.
    Time Frame
    Weeks 4, 8, and 12
    Title
    Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia.
    Time Frame
    Weeks 4, 8, and 12
    Title
    The change from baseline SODA scale for subjects with dyspepsia at baseline.
    Time Frame
    Weeks 4, 8, and 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Takeda
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17916545
    Citation
    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. doi: 10.1016/j.cgh.2007.06.009.
    Results Reference
    result

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

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