Phase 3
N=420
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
Gastric Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01129011 ↗Enrolled (actual)
420
Serious AEs
2.9%
Results posted
Dec 2010
Primary outcome: Primary: Number of Participants With Gastric Ulcer Confirmed by Endoscopy — 15; 51 Participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PN400 (VIMOVO) (Drug); Naproxen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- POZEN
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Gastric Ulcer Confirmed by Endoscopy |
15; 51 | 0.001 sig |
| SECONDARY The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers |
114; 151 | 0.001 sig |
| SECONDARY The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer |
10; 25 | 0.009 sig |
| SECONDARY The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment |
2; 12 | 0.007 sig |
| SECONDARY Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit |
102; 62 | 0.001 sig |
| SECONDARY Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire |
79; 63 | — |
| SECONDARY Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales |
-3; 0 | — |
| SECONDARY Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales |
-1.1; 0.1 | — |
| SECONDARY Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales |
1.9; 0.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
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);
- 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 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
Data sourced from ClinicalTrials.gov (NCT01129011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.