A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00527904
First received: September 10, 2007
Last updated: August 27, 2010
Last verified: August 2010
  Purpose

This study uses an open-label design and will be conducted in approximately 60 sites aiming to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12 months exposure to PN400 (VIMOVO).


Condition Intervention Phase
Gastric Ulcer
Drug: PN400 (VIMOVO)
Drug: PN 400 (VIMOVO)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 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:
  • Number of Subjects Monitored for Long-term Safety of PN 400 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses taken and by treatment window.


Enrollment: 239
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PN 400 (VIMOVO)
500 mg delayed release naproxen/20 mg immediate release esomeprazole
Drug: PN400 (VIMOVO)
Subjects are instructed to take 2 tablets a day, one in the morning and one in the afternoon/evening. The morning tablet should be taken with water, on an empty stomach 30 to 60 minutes before breakfast, or the first meal. The afternoon/evening tablet should be taken with water, on an empty stomach 30 to 60 minutes before dinner. Tablets should be swallowed whole and not broken, crushed or chewed.
Other Names:
  • Naprosyn
  • Nexium
Drug: PN 400 (VIMOVO)
500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months
Other Names:
  • Naprosyn
  • Nexium

Detailed Description:

PN400 is proposed for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 12 months in patients at risk for developing NSAID-associated gastric ulcers. This study is designed to provide long-term safety data for PN400 in order to gain regulatory approval to make PN400 available for clinical use in this subject population.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

A subject was eligible for inclusion in this study if all of the following criteria applied:

  1. 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 12 months:

    who were

    • 18-49 years of age and had 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 were
    • 50 years of age and older (These subjects did not require a history of a documented, uncomplicated gastric or duodenal ulcer within the past 5 years).
  2. Female subjects were eligible for participation in the study if they were of

    • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant);
    • Childbearing potential, had negative pregnancy test at Screening, and at least 1 of the following applied or was agreed to by the subject:
    • Female sterilization or sterilization of male partner; or,
    • Hormonal contraception by oral route, implant, injectable, vaginal ring; or,
    • Any intrauterine device with published data showing that the lowest expected failure rate is less than 1% per year; or,
    • 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
  3. Each subject was required to be able and willing to provide written informed consent prior to any study procedures being performed.

Exclusion Criteria

A subject was not eligible for inclusion in this study if any 1 or more of the following criteria applied:

  1. History of hypersensitivity to esomeprazole or to another PPI
  2. History of allergic reaction or intolerance to any NSAID (including aspirin) and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
  3. Participation in any study of an investigational treatment in the 4 weeks before Screening
  4. Presence of uncontrolled acute or chronic medical illness, e.g., GI disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would have endangered a subject if he/she were to participate in the study
  5. GI disorder or surgery leading to impaired drug absorption
  6. Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder which in the investigator's opinion would have endangered a subject if he/she were to participate in the study
  7. Schizophrenia or bipolar disorder
  8. Use of any excluded concomitant medication
  9. 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
  10. Serious blood coagulation disorder, including use of systemic anticoagulants
  11. Positive test result for Helicobacter pylori at Screening
  12. Baseline endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth
  13. Screening laboratory value for any of the following tests that was > 2 times the upper limit of normal: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
  14. Estimated creatinine clearance < 50 mL/min
  15. Other than noted specifically, any screening laboratory value that was clinically significant in the investigator's opinion and would have endangered a subject if the subject were to participate in the study
  16. 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: NCT00527904

Locations
United States, North Carolina
POZEN
Chapel Hill, North Carolina, United States, 27519
Sponsors and Collaborators
POZEN
Investigators
Study Chair: Everardus Orlemans, PhD POZEN
  More Information

No publications provided by POZEN

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Senior Vice President, Clinical Research, Pozen Inc.
ClinicalTrials.gov Identifier: NCT00527904     History of Changes
Other Study ID Numbers: PN400-304
Study First Received: September 10, 2007
Results First Received: May 28, 2010
Last Updated: August 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by POZEN:
osteoarthritis
rheumatoid arthritis
ankylosing spondylisit
NSAIDS

Additional relevant MeSH terms:
Stomach Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 16, 2014