Advertisement

Topics

PN400-302, A 6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study to Evaluate the Incidence of Gastric

2014-08-27 03:13:28 | BioPortfolio

Summary

This study uses a randomized, double-blind, controlled design and will be conducted in approximately 60 sites aiming to enroll a total number of 400 subjects (200 per arm). A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed, or the endpoint has been reached: gastric ulcer confirmed by endoscopy.

Description

Objectives:

Primary: To demonstrate that PN 400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.

Secondary:

To determine if PN 400 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 PN 400 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 PN 400 versus naproxen To evaluate the safety and tolerability of PN 400 and naproxen

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Gastric Ulcer

Intervention

PN400, Naproxen

Status

Completed

Source

POZEN

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:28-0400

Clinical Trials [1227 Associated Clinical Trials listed on BioPortfolio]

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E

The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as ...

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E

The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as ...

Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®

LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulce...

Study to Evaluate the Incidence of Gastric Ulcers With PN 400 (Esomeprazole/Naproxen) Versus Diclofenac/Misoprostol in Subjects Who Are at High Risk for Developing NSAID-Associated Ulcers

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 PN 400 versus dic...

PubMed Articles [1442 Associated PubMed Articles listed on BioPortfolio]

Porcine stomachs with and without gastric ulcer differ in Lactobacillus load and strain characteristics.

Although Lactobacillus species are recognized as normal inhabitants of porcine gastric mucosa, the association of these bacteria with health status or gastric ulcer disease has never been considered. ...

Effects of artemisinin, with or without lumefantrine and amodiaquine on gastric ulcer healing in rat.

Antimalarial drugs have been shown to predispose the stomach to ulceration in rats. However, their role in the modulation of gastric ulcer healing is not known. The aim of the present study is to inve...

Risk factors for adverse course of gastric and duodenal peptic ulcer.

Introduction: High morbidity rate, frequent relapses, and significant economic losses give reasons for highlighting the peptic ulcer disease as the most topical medical-statistical problem. The aim of...

Antioxidant and anti-inflammatory activities of alpha lipoic acid protect against indomethacin-induced gastric ulcer in rats.

Little is known about the role of tumor necrosis factor-alpha (TNF-α), plasminogen activator inhibitor-1 (PAI-1), and inducible nitric oxide synthase (iNOS) in the gastric ulcer and the effect of alp...

Combination therapy with polydeoxyribonucleotide and proton pump inhibitor enhances therapeutic effectiveness for gastric ulcer in rats.

The main action of proton pump inhibitors (PPIs) is to inhibit gastric acid secretion, and PPIs are widely used to treat gastric ulcer (GU). However, if the action of promoting gastric mucosal regener...

Medical and Biotech [MESH] Definitions

Ulcer that occurs in the regions of the GASTROINTESTINAL TRACT which come into contact with GASTRIC JUICE containing PEPSIN and GASTRIC ACID. It occurs when there are defects in the MUCOSA barrier. The common forms of peptic ulcers are associated with HELICOBACTER PYLORI and the consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).

Ulceration of the GASTRIC MUCOSA due to contact with GASTRIC JUICE. It is often associated with HELICOBACTER PYLORI infection or consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).

That portion of the stomach remaining after gastric surgery, usually gastrectomy or gastroenterostomy for cancer of the stomach or peptic ulcer. It is a common site of cancer referred to as stump cancer or carcinoma of the gastric stump.

Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief.

Abnormal distention of the STOMACH due to accumulation of gastric contents that may reach 10 to 15 liters. Gastric dilatation may be the result of GASTRIC OUTLET OBSTRUCTION; ILEUS; GASTROPARESIS; or denervation.

More From BioPortfolio on "PN400-302, A 6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study to Evaluate the Incidence of Gastric"

Advertisement
Quick Search
Advertisement
Advertisement

 

Searches Linking to this Trial