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OpenTrials
Completed

NCT Number: NCT00701259

Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

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.

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Key information

Conditions

Frequent Heartburn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Not applicable - enrollment complete

Parsippany, New Jersey, 07054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Experiencing heartburn at least 2 days per week during the nighttime period over the past month.
  • Having heartburn that responds to heartburn medication.
  • Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion criteria

  • Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
  • Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.

"Other protocol-defined inclusion/exclusion criteria may apply"

Treatment and study plan

Lansoprazole

Drug

Lansoprazole 15 mg once per day for 14 days

Other names: Prevacid - United States

Placebo

Drug

Primary outcomes

  1. Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.

    Time frame: 14 days

Secondary outcomes

  1. Proportion of 24 hour days with no heartburn during 14 days of treatment. Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose. The evaluation of lansoprazole safety.

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of Fourteen Day Treatment With Lansoprazole 15 mg or 30 mg Once a Day in Frequent Nighttime Heartburn

Important dates

Study start
2007
Study completion
2007
First posted
Jun 19, 2008
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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