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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 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.
ClinicalTrials.gov Identifier: NCT00367211
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : April 22, 2008
Sponsor:
Information provided by:
POZEN

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Ankylosing Spondylitis Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole) Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole) Phase 3

Expanded Access : POZEN has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : September 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007





Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. The secondary efficacy variable is the incidence of duodenal ulcers at any time throughout 6 months of treatment, tolerability and safety.


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
Criteria

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:

    1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
    2. 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.

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 ClinicalTrials.gov identifier (NCT number): NCT00367211


Locations
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United States, Florida
Patient Interaction
Pompano Beach, Florida, United States, 33069
Sponsors and Collaborators
POZEN

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Responsible Party: David Taylor, Pozen Inc.
ClinicalTrials.gov Identifier: NCT00367211     History of Changes
Other Study ID Numbers: PN200-301
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by POZEN:
Gastric Ulcers
NSAID
Arthritis

Additional relevant MeSH terms:
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Spondylitis
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Stomach Ulcer
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Naproxen
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors