Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec

NCT00594854 | Terminated Phase 3 Results DMC

• 1 other identifier: PN400-303
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per arm). At least 20% of the subjects enrolled will be age 65 years and older.

Conditions

Gastric Ulcer

Keywords

NSAID; Gastric Ulcer; High risk; Arthrotec; Vimovo

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Gastric Ulcer Confirmed by Endoscopy

  Number of participants with gastric ulcers confirmed by endoscopy following administration of PN 400 (VIMOVO) or Arthrotec in a high risk population over six months.

  6 months

Secondary Outcomes (2)

• Number of Participants With Duodenal Ulcers Confirmed by Endoscopy

  6 months

• Number of Participants With Upper Gastro-intestinal Injury Grade 4 as Measured by Lanza (1991) Score

  6 months

Study Arms (2)

PN400

EXPERIMENTAL

PN 400 (esomeprazole/naproxen) dosed twice daily

Drug: PN400 (VIMOVO)

Diclofenac/Misoprostol

ACTIVE COMPARATOR

diclofenac 75mg/misoprostol 200 mcg dosed twice daily

Drug: Diclofenac/Misoprostol

Interventions

PN400 (VIMOVO) DRUG

PN400 tablet (500 mg delayed-release naproxen/20 mg immediate-release esomeprazole) given by mouth twice daily (bid).

Also known as: Vimovo

PN400

Diclofenac/Misoprostol DRUG

Over-encapsulated ARTHROTEC® 75 (75 mg diclofenac sodium/200 mcg misoprostol) capsules given by mouth bid.

Also known as: Arthrotec

Diclofenac/Misoprostol

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, 18 years and older with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical condition expected to require daily NSAID therapy for at least 6 months, with a documented history of an ulcer related serious upper gastrointestinal event such as bleeding, perforation or obstruction
• Female subjects are eligible for participation in the study if they are of:
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant);
• Childbearing potential, have a negative pregnancy test at screening, and at least one of the following applies or is 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 (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

You may not qualify if:

• History of hypersensitivity to esomeprazole or to another proton-pump inhibitor
• 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
• Positive test result for H. pylori at screening
• 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, hypertension, diabetes, 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
• Screening endoscopy showing \>10 erosions or any gastric or duodenal ulcer at least 3 mm in diameter with depth
• Screening laboratory ALT or AST value \> 2 times the upper limit of normal
• Estimated creatinine clearance \< 50 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

Sponsors & Collaborators

• POZEN: lead

Study Sites (1)

POZEN

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Stomach Ulcer

Interventions

Arthotec; Arthrotec

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Limitations and Caveats

Early termination due to small number of subjects.

Results Point of Contact

• Title: Senior Vice President, Clinical Research
• Organization: Pozen Inc.

eorlemans@pozen.com

919-913-1030

Study Officials

• Everardus Orlemans, PhD

  POZEN

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: January 16, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 22, 2010
• Results First Posted: September 22, 2010

Record last verified: 2010-08

Locations

US (1)