Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

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

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.

Study Overview

• Status: Completed
• Conditions: Heartburn
• Intervention / Treatment: Drug: Lanzoprazole

• Study Type: Interventional
• Enrollment: 576
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Hoover, Alabama, United States, 35216
      • Clinical Research Consultants Inc.
    • Huntsville, Alabama, United States, 35802
  • Arizona
    • Sierra Vista, Arizona, United States, 85635
      • Radiant Research
  • California
    • Los Angeles, California, United States, 90025
      • California Bio Medical Research Institute
    • Roseville, California, United States, 95678
      • Allergy Medical Group of North Area
  • Florida
    • Hialeah, Florida, United States, 33013
      • Eastern Research
    • Jupiter, Florida, United States, 33458
      • Health Awareness Inc.
    • Miami, Florida, United States, 33173
      • Miami Research Associates
  • Georgia
    • Atlanta, Georgia, United States, 30252
      • Radiant Research
    • Atlanta, Georgia, United States, 30308
      • Radiant Research
  • Indiana
    • Evansville, Indiana, United States, 47714
  • Maryland
    • Reisterstown, Maryland, United States, 21136
      • Clinical Associates
  • Missouri
    • St. Louis, Missouri, United States, 63117
      • Medex Healthcare Research, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research LLC
  • New Mexico
    • Rio Rancho, New Mexico, United States, 87124
      • William W. Anderson M.D. P.C.
  • New York
    • Port Chester, New York, United States, 10573
      • IRSI
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Crescent Medical Research
  • Ohio
    • Columbus, Ohio, United States, 43204
      • Micheal Alexander, DO
  • Oregon
    • Portland, Oregon, United States, 97219
      • New Hope Research of Oregon
  • Pennsylvania
    • Carnegie, Pennsylvania, United States, 15106
      • Preferred Primary Care Physicians
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Advanced Therapeutics, Inc
    • Nashville, Tennessee, United States, 37205
      • Nashville Medical Research
  • Texas
    • Dallas, Texas, United States, 75243
      • Medical Edge Healthcare Group, P.A.
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research
    • San Angelo, Texas, United States, 76904
      • Benchmark Research
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Commonwealth Clinical Research Specialist
    • Richmond, Virginia, United States, 23294
      • National Clinical Research Inc.
  • Washington
    • Lakewood, Washington, United States, 98499
      • Radiant Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: October 18, 2006
• First Submitted That Met QC Criteria: October 18, 2006
• First Posted (Estimate): October 19, 2006

Study Record Updates

• Last Update Posted (Estimate): April 16, 2007
• Last Update Submitted That Met QC Criteria: April 13, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Keywords: Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn
• Other Study ID Numbers: PRSW-GN-301