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Prevacid Naprapac (Lansoprazole / Naproxen) - Summary

 
 



SUMMARY

PREVACID® NapraPAC™ 375 is a combination package containing NAPROSYN 375 mg tablets and PREVACID 15 mg capsules. PREVACID® NapraPAC™ 500 is a combination package containing NAPROSYN 500 mg tablets and PREVACID 15 mg capsules.

PREVACID® NapraPAC™ (375 or 500) is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of documented gastric ulcer who require the use of an NSAID for treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.) Controlled studies did not extend beyond 12 weeks.


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NEWS HIGHLIGHTS

Published Studies Related to Prevacid Naprapac (Lansoprazole / Naproxen)

Exhaled breath condensate pH does not discriminate asymptomatic gastroesophageal reflux or the response to lansoprazole treatment in children with poorly controlled asthma. [2014]
life, and increased formation of breath nitrogen oxides (NOx)... CONCLUSION: Despite the relative ease of EBC collection, EBC pH as a biomarker

Distinguishing the impact of dexlansoprazole on heartburn vs. regurgitation in patients with gastro-oesophageal reflux disease. [2013]
(EE)... CONCLUSIONS: Dexlansoprazole appears to be effective in improving both heartburn

A multicenter, randomized, comparative study to determine the appropriate dose of lansoprazole for use in the diagnostic test for gastroesophageal reflux disease. [2011.09]
BACKGROUND/AIMS: The diagnostic proton pump inhibitor test (PPI test) is a method used in diagnosing gastroesophageal reflux disease (GERD). This study aimed to determine the appropriate dose of lansoprazole for use in the diagnostic test for GERD... CONCLUSIONS: In this multicenter, randomized study of Korean patients, the standard dose of lansoprazole was as effective as a high dose of lansoprazole in relieving the symptoms of GERD, regardless of the presence of ERD, by day 14 of treatment.

Preventive effects of lansoprazole and famotidine on gastric mucosal injury induced by low-dose aspirin in Helicobacter pylori-negative healthy volunteers. [2011.07]
The preventive effects of lansoprazole and famotidine on low-dose aspirin-induced gastric mucosal injury in relation to gastric acidity were compared in healthy Japanese volunteers. Fifteen Helicobacter pylori-negative volunteers with different CYP2C19 genotypes were randomly administered aspirin 100 mg, aspirin plus famotidine 20 mg twice daily, or aspirin plus lansoprazole 15 mg once daily for 7 days each in a crossover fashion.

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term low-dose aspirin therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial. [2011.06]
BACKGROUND: The efficacy of low-dose lansoprazole has not been established for the prevention of recurrent gastric or duodenal ulcers in those receiving long-term low-dose aspirin (LDA) for cardiovascular and cerebrovascular protection. This study sought to examine the efficacy of low-dose lansoprazole (15 mg once daily) for the secondary prevention of LDA-associated gastric or duodenal ulcers... CONCLUSION: Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term LDA therapy.

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Clinical Trials Related to Prevacid Naprapac (Lansoprazole / Naproxen)

Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer [Completed]
The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.

Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain [Withdrawn]
The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP. The patient will undergo esophageal balloon distention testing (EBDT) before and after taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical properties of the esophagus. A catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will be done throughout the study as a measurement of safety.

Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants [Completed]
The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.

Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months [Not yet recruiting]
The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) [after daily administration for 7 days] and safety [after daily administration for 8 weeks] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.

Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis [Completed]
This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.

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Page last updated: 2015-08-10

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