Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

• ClinicalTrials.gov Identifier: NCT00389948
• Recruitment Status: Completed
• First Posted: October 19, 2006
• Last Update Posted: April 16, 2007
• Sponsor: Novartis
• Information provided by: Novartis

Tracking Information

• First Submitted Date: October 18, 2006
• First Posted Date: October 19, 2006
• Last Update Posted Date: April 16, 2007
• Study Start Date: June 2006
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: October 18, 2006): To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 18, 2006)

• To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
• To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
• Evaluation of lansoprazole safety.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
• Official Title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Heartburn
• Intervention: Drug: Lanzoprazole
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: October 18, 2006): 576
• Original Enrollment: Same as current
• Actual Study Completion Date: January 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
2. 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 or exclusion criteria may apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00389948
• Other Study ID Numbers: PRSW-GN-301
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Novartis
• Verification Date: April 2007