- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00367211
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.
April 21, 2008 updated by: POZEN
A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.
The purpose of this study is to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment
400
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Pompano Beach, Florida, United States, 33069
- Patient Interaction
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or non-pregnant female subjects with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 6 months who are 18-49 years of age and have a history of a documented, uncomplicated gastric or duodenal ulcer (a mucosal break of at least 3 mm in diameter with depth, without any concurrent bleeding, clot or perforation) within the past 5 years OR, who are 50 years of age and older (these subjects do not require a history of a documented, uncomplicated gastric or duodenal ulcer within the past 5 years).
Female subjects are eligible for participation in the study if they are of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
Childbearing potential, have a negative pregnancy test (urine) at screening, and at least one of the following applies or is agreed to by the subject:
- Complete abstinence from intercourse for at least 14 days prior to first dose of study drug, throughout the study, and for 30 days after completion of the study
- Female sterilization or sterilization of male partner; or,
- Hormonal contraception by oral route, implant, injectable, vaginal ring; or,
- Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year;
- Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or
- Any other method with published data showing that the lowest expected failure rate is less than 1% per year.
- Each subject must be able to understand and comply with study procedures required of a subject and is able and willing to provide written informed consent prior to any study procedures being performed.
Exclusion Criteria:
- History of hypersensitivity to omeprazole or to another proton-pump inhibitor.
- History of allergic reaction or intolerance to any NSAID (including aspirin) and/or subject has a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps.
- Participation in any study of an investigational treatment in the 4 weeks before screening.
- Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal disorder, diabetes, hypertension, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study.
- Gastrointestinal disorder or surgery leading to impaired drug absorption.
- Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would endanger a subject if they were to participate in the study.
- Schizophrenia or bipolar disorder.
- Use of any excluded concomitant medication (see Section 9.2).
- A recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse/abuse of narcotics for management of pain.
- Serious blood coagulation disorder including use of systemic anticoagulants.
- Positive test result for H. pylori at screening.
- Baseline endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth.
- Screening laboratory value for ALT, AST >2 times the upper limit of normal.
- Estimated creatinine clearance < 30 ml/min.
- Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if they were to participate in the study.
- History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary efficacy variable is the incidence of gastric ulcers, defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with depth, at anytime throughout 6 months of study treatment.
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Secondary Outcome Measures
Outcome Measure |
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The secondary efficacy variable is the incidence of duodenal ulcers at any time throughout 6 months of treatment, tolerability and safety.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
August 18, 2006
First Submitted That Met QC Criteria
August 21, 2006
First Posted (Estimate)
August 22, 2006
Study Record Updates
Last Update Posted (Estimate)
April 22, 2008
Last Update Submitted That Met QC Criteria
April 21, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Gastrointestinal Diseases
- Stomach Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Intestinal Diseases
- Spinal Diseases
- Bone Diseases
- Peptic Ulcer
- Duodenal Diseases
- Spondylarthropathies
- Spondylarthritis
- Bone Diseases, Infectious
- Ankylosis
- Arthritis
- Stomach Ulcer
- Spondylitis
- Spondylitis, Ankylosing
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Gout Suppressants
- Omeprazole
- Naproxen
Other Study ID Numbers
- PN200-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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