AzTrials
AzTrials

Gastric UlcerPhase 3NCT00527787

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen

A Phase 3 study testing PN400 (VIMOVO) and Naproxen in people with Gastric Ulcer, run by POZEN at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Ulcer
What is being tested?
PN400 (VIMOVO) and Naproxen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
434 participants
Where
1 siteUnited States
Study dates
Sep 2007to Oct 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject was eligible for inclusion in this study if all of the following criteria applied:
  • Male or non-pregnant, non-breastfeeding 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 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.)
  • Female subjects were eligible for participation in the study if they were of
  • non-childbearing potential (i.e., physiologically incapable of becoming pregnant);
Show all 13Show fewer
  • childbearing potential, had a 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
  • Hormonal contraception by oral route, implant, injectable, vaginal ring
  • Any intrauterine device with published data showing that the lowest expected failure rate is < 1% per year
  • Double barrier method (2 physical barriers or 1 physical barrier plus spermicide)
  • Any other method with published data showing that the lowest expected failure rate is < 1% per year
  • Each subject was required to understand and comply with study procedures required of a subject and was able and willing to provide written informed consent prior to any study procedures being performed.

Who cannot join

  • A subject was not eligible for this study if any 1 or more of the following criteria applied:
  • 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 they were to have participated in the study
  • GI disorder or surgery leading to impaired drug absorption
Show all 17Show fewer
  • Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would have endangered a subject if they were to have participated in the study
  • Schizophrenia or bipolar disorder
  • Use of any excluded concomitant medication (see Section 9.4.8)
  • 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
  • Screening endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth
  • Screening laboratory alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 2 times the upper limit of normal
  • Estimated creatinine clearance < 30 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 they were to have participated 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • POZEN

    Chapel Hill, North Carolina, 27517

Other trials in United States

About this study

Official title: 6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study Evaluate Gastric Ulcer Incidence Following Administration of PN400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-associated Ulcers

This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.

Read the detailed description

Objectives:

Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.

Secondary:

  • To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers
  • To compare upper gastrointestinal symptoms in subjects treated with PN400 versus naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument and the Overall Treatment Evaluation - Dyspepsia (OTE-DP)
  • To compare heartburn symptoms in subjects treated with PN400 versus naproxen
  • To evaluate the safety and tolerability of PN400 and naproxen
Conditions
Gastric Ulcer
Being tested
PN400 (VIMOVO), Naproxen
Keywords
NSAID, gastric ulcers, Vimovo, Naproxen, Esomeprazole
Medical subject headings
Stomach Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PN400 (VIMOVO)Drug

    Also called Vimovo

    PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally.

  • NaproxenDrug

    Also called Naprosyn

    Naproxen (500 mg) dosed twice daily (bid) orally

Study groups in NCT00527787
Study groupRoleWhat they receive
PN400ExperimentalNaproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily
Receives: Drug: PN400 (VIMOVO)
NaproxenActive comparatorNaproxen 500 mg dosed twice daily
Receives: Drug: Naproxen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Gastric Ulcer Confirmed by Endoscopy

    The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.

    Measured: 6 months

Secondary outcomes (8)

  1. The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers

    The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort

    Measured: 6 months

  2. The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer

    The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period

    Measured: 6 Months

  3. The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment

    The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period

    Measured: 6 months

  4. Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit

    Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:

    • none: no symptoms
    • mild: awareness of symptom, but easily tolerated
    • moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)
    • severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck.

    Measured: 6 months

  5. Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire

    Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: "since treatment started, has there been any change in your upper abdominal pain and/or discomfort?" Answers would be better/about the same/worse. Participants with the response "better" (instead of "about the same" or "worse"), are tabulated by treatment group.

    Measured: change from baseline at 6 Months

  6. Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales

    Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for "pain intensity" is: 2-47

    Measured: baseline to 6 Months

  7. Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales

    Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.

    Measured: baseline to 6 Months

  8. Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales

    Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) \& statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) \& question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23

    Measured: baseline to 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00527787
Sponsor's protocol ID
PN400-301
Status last verified
Nov 2010
First submitted
10 Sep 2007
Last updated
28 Dec 2010
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PN400 (VIMOVO) and Naproxen in people with Gastric Ulcer, run by POZEN at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Gastric Ulcer Confirmed by Endoscopy (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00527787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in