Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
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|ClinicalTrials.gov Identifier: NCT00594854|
Recruitment Status : Terminated (POZEN agreed with FDA to stop study due to low and inadequate enrollment)
First Posted : January 16, 2008
Results First Posted : September 22, 2010
Last Update Posted : September 22, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Ulcer||Drug: PN400 (VIMOVO) Drug: Diclofenac/Misoprostol||Phase 3|
To determine the incidence of gastric ulcers following administration of PN 400 in a high risk population over six months. Diclofenac/misoprostol will be used as a positive control.
- To determine the incidence of duodenal ulcers during treatment with PN 400 and diclofenac/misoprostol in a high risk population
- To evaluate the degree of upper gastrointestinal injury as measured by Lanza scores (1991) during treatment with PN400 and diclofenac/misoprostol in a high risk population
- To compare gastrointestinal symptoms in subjects treated with PN 400 versus diclofenac/misoprostol as measured by scores on the Gastrointestinal Symptoms Rating Scale (GSRS) instrument
- To evaluate the safety and tolerability of PN400 and diclofenac/misoprostol in a high risk population
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||6-Month, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study of Gastric Ulcer Incidence With PN400 (Esomeprazole/Naproxen) Versus Diclofenac/Misoprostol in Subjects at High Risk for Developing NSAID-Associated Ulcers|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
PN 400 (esomeprazole/naproxen) dosed twice daily
Drug: PN400 (VIMOVO)
PN400 tablet (500 mg delayed-release naproxen/20 mg immediate-release esomeprazole) given by mouth twice daily (bid).
Other Name: Vimovo
Active Comparator: Diclofenac/Misoprostol
diclofenac 75mg/misoprostol 200 mcg dosed twice daily
Over-encapsulated ARTHROTEC® 75 (75 mg diclofenac sodium/200 mcg misoprostol) capsules given by mouth bid.
Other Name: Arthrotec
- Number of Participants With Gastric Ulcer Confirmed by Endoscopy [ Time Frame: 6 months ]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.
- Number of Participants With Duodenal Ulcers Confirmed by Endoscopy [ Time Frame: 6 months ]Number of participants with duodenal ulcers confirmed by endoscopy following administration of PN 400 VIMOVO)or Arthrotec in a high risk population
- Number of Participants With Upper Gastro-intestinal Injury Grade 4 as Measured by Lanza (1991) Score [ Time Frame: 6 months ]The degree of upper gastrointestinal (UGI) injury as measured by Lanza scores (1991) during treatment with PN 400 and ARTHROTEC® in a high-risk population. The Lanza (1991) score is based on endoscopic obeservations and rating these, with no damage, petecchiae, erosions and ulcers. On the 1991 scale, a Lanza score of 0 represents normal mucosa (no damage), while a score of 4 indicates 6-10 erosions, and a score of 7 indicates an ulcer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594854
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27517|
|Study Chair:||Everardus Orlemans, PhD||POZEN|