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

NCT00527904 | Completed Phase 3 Results DMC

• 1 other identifier: PN400-304
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Gastric Ulcer

Keywords

osteoarthritis; rheumatoid arthritis; ankylosing spondylisit; NSAIDS

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Monitored for Long-term Safety of PN 400

  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.

  12 months

Study Arms (1)

PN 400 (VIMOVO)

EXPERIMENTAL

500 mg delayed release naproxen/20 mg immediate release esomeprazole

Drug: PN400 (VIMOVO); Drug: PN 400 (VIMOVO)

Interventions

PN400 (VIMOVO) DRUG

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.

Also known as: Naprosyn, Nexium

PN 400 (VIMOVO)

PN 400 (VIMOVO) DRUG

500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months

Also known as: Naprosyn, Nexium

PN 400 (VIMOVO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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).
• 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
• Each subject was required to be able and willing to provide written informed consent prior to any study procedures being performed.

You may not qualify if:

• History of hypersensitivity to esomeprazole or to another PPI
• 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
• Participation in any study of an investigational treatment in the 4 weeks before Screening
• 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
• GI disorder or surgery leading to impaired drug absorption
• 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
• Schizophrenia or bipolar disorder
• Use of any excluded concomitant medication
• 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 Helicobacter pylori at Screening
• Baseline endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth
• 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)
• Estimated creatinine clearance \< 50 mL/min
• 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

Sponsors & Collaborators

• POZEN: lead

Study Sites (1)

POZEN

Chapel Hill, North Carolina, 27519, United States

Location

Related Publications (1)

• Sostek MB, Fort JG, Estborn L, Vikman K. Long-term safety of naproxen and esomeprazole magnesium fixed-dose combination: phase III study in patients at risk for NSAID-associated gastric ulcers. Curr Med Res Opin. 2011 Apr;27(4):847-54. doi: 10.1185/03007995.2011.555756. Epub 2011 Feb 14.

  PMID: 21319944 DERIVED

MeSH Terms

Conditions

Stomach Ulcer; Osteoarthritis; Arthritis, Rheumatoid

Interventions

Naproxen; Esomeprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Vice President, Clinical Research
• Organization: POZEN

eorlemans@pozen.com

919-913-1030

Study Officials

• Everardus Orlemans, PhD

  POZEN

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 31, 2010
• Results First Posted: August 20, 2010

Record last verified: 2010-08

Locations

US (1)