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.

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00367211
First received: August 18, 2006
Last updated: April 21, 2008
Last verified: April 2008
  Purpose

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 Intervention 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

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by POZEN:

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

Estimated Enrollment: 400
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367211

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

No publications provided

Responsible Party: David Taylor, Pozen Inc.
ClinicalTrials.gov Identifier: NCT00367211     History of Changes
Other Study ID Numbers: PN200-301
Study First Received: August 18, 2006
Last Updated: April 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by POZEN:
Gastric Ulcers
NSAID
Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Spondylitis
Spondylitis, Ankylosing
Stomach Ulcer
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
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on August 28, 2014