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)
Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. [2009.09.04]
SUMMARY Background Dexlansoprazole MR is a Dual Delayed Release formulation of dexlansoprazole, an enantiomer of lansoprazole. Aim To assess safety of dexlansoprazole MR in phase 3 clinical trials Methods Data from 4270 patients receiving dexlansoprazole MR 30 mg (n=455), 60 mg (n=2311), or 90 mg (n=1864); lansoprazole 30 mg (n=1363); or placebo (n=896) in 6 randomized controlled trials and a 12-month safety study were pooled...
A randomized, single-blind study of lansoprazole for the prevention of exacerbations of chronic obstructive pulmonary disease in older patients. [2009.08]
OBJECTIVES: To investigate whether proton pump inhibitor (PPI) therapy reduces the frequency of common colds and exacerbations in patients with chronic obstructive pulmonary disease (COPD)... CONCLUSION: In this single-blind, nonplacebo-controlled trial, lansoprazole was associated with a significant decrease in COPD exacerbations. More definitive clinical trials are warranted.
Long-term efficacy of lansoprazole in preventing relapse of erosive reflux esophagitis. [2009.08]
In a phase III study of lansoprazole treatment, patients with healed or unhealed erosive esophagitis entered a titrated open-label treatment period and received lansoprazole for <or=6 years to assess long-term maintenance therapy. Doses were adjusted depending on symptom response.Long-term lansoprazole is effective and well tolerated when used to maintain erosive esophagitis remission for <or=6 years.
Lansoprazole 15 mg once daily for 14 days is effective for treatment of frequent heartburn: results of 2 randomized, placebo-controlled, double-blind studies. [2009.07]
OBJECTIVE: To investigate the efficacy and safety of a 14-day treatment period with lansoprazole 15 mg for frequent heartburn in patients who are likely to select a nonprescription medication before consulting a prescriber... CONCLUSION: During the 14-day treatment period in a population with frequent heartburn who were likely to select a medication without consulting a prescriber, lansoprazole 15 mg once daily showed rapid and sustained effectiveness throughout a 24-hour period and was well tolerated.
Lansoprazole for long-term maintenance therapy of erosive esophagitis: double-blind comparison with ranitidine. [2009.05]
In a study evaluating the efficacy and safety of lansoprazole to prevent the relapse of erosive esophagitis (EE), 206 of 241 patients (85%) healed after open-label treatment with lansoprazole 30 mg once daily for 8 weeks and received double-blind maintenance treatment with lansoprazole 15 mg once daily or ranitidine 150 mg twice daily for up to 1 year...
Clinical Trials Related to Prevacid Naprapac (Lansoprazole / Naproxen)
Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis [Completed]
The objective of this study was to compare the pharmacodynamics of intravenous (IV)
lansoprazole 30 mg to oral lansoprazole 30 mg capsules in subjects with erosive esophagitis.
Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent GERD [Completed]
A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg
twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD)
with continued heartburn symptoms with a course of therapy of 30 mg twice daily
Lansoprazole.
Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn [Completed]
Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic
stomach contents move upward into the esophagus from the stomach. This study will
investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in
preventing frequent nighttime heartburn.
A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients [Completed]
This study looks at controlling intragastric pH following administration of esomeprazole 40
mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking
either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory
drugs (NSAIDs).
Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn [Completed]
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic
stomach contents move into the esophagus from the stomach. This study will investigate the
safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.
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