Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

Official 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”

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.

Intervention(s) in this Clinical Trial

• Drug: Lansoprazole
  • Lansoprazole 15 mg once per day for 14 days
• Drug: Lansoprazole
  • Lansoprazole 30 mg once per day for 14 days
• Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 15 mg lansoprazole
• Experimental: 2
  • 30 mg lansoprazole
• Placebo Comparator: 3
  • placebo

Primary Measures

• Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.
  • Time Frame: 14 days
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

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"

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00701259

Study ID Number: PRSW-GN-305

ClinicalTrials.gov Identifier: NCT00701259

Health Authority: United States: Food and Drug Administration