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Clinical trial: lansoprazole 15 or 30 mg once daily vs. placebo for treatment of frequent nighttime heartburn in self-treating subjects.

AbstractBACKGROUND:
Frequent nighttime heartburn is common. Lansoprazole 15 mg is indicated for treatment of heartburn and other gastro-oesophageal reflux disease-related symptoms.
AIM:
To evaluate the efficacy and safety of lansoprazole in self-treating subjects with frequent nocturnal heartburn.
METHODS:
A total of 864 subjects with heartburn on >or=2 days/week over the past month were randomized to double-blind treatment with lansoprazole 15 or 30 mg or placebo each morning. Endpoints were percentage of night times without heartburn (primary), percentage of 24-h days without heartburn and percentage of subjects without heartburn on day 1.
RESULTS:
Mean percentage of night times without heartburn was significantly greater with lansoprazole 15 mg (61.3%) or lansoprazole 30 mg (61.7%) vs. placebo (47.8%) over 14 days (P < 0.0001 vs. placebo for both doses). Percentage of 24-h days without heartburn and percentage of subjects without heartburn on day 1 were significantly greater with lansoprazole 15 or 30 mg vs. placebo.
CONCLUSIONS:
Both lansoprazole 15 and 30 mg were highly effective and well tolerated in reducing symptoms in subjects with frequent nighttime heartburn. The benefit of therapy on 24-h heartburn and nighttime heartburn on day 1 of treatment was also evident. Lansoprazole 15 mg is a suitable choice for management of frequent nighttime heartburn.
AuthorsD A Peura, D S Riff, A M Snoddy, M B Fennerty
JournalAlimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 30 Issue 5 Pg. 459-68 (Sep 1 2009) ISSN: 1365-2036 [Electronic] England
PMID19523177 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Lansoprazole
Topics
  • 2-Pyridinylmethylsulfinylbenzimidazoles (administration & dosage)
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Ulcer Agents (administration & dosage)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Heartburn (drug therapy)
  • Humans
  • Lansoprazole
  • Male
  • Middle Aged
  • Young Adult

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