Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

Frequent Heartburn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701259
• Other study ID #: PRSW-GN-305
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2008
• Last updated: January 13, 2010
• Start date: January 2007
• Est. completion date: August 2007

Study information

• Verified date: January 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 852
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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"

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Frequent Heartburn
• Heartburn

Intervention

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

Locations

Country	Name	City	State
United States	Not applicable - enrollment complete	Parsippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.		14 days	No
Secondary	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.		14 days	No