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Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Primary Purpose

Heartburn

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lanzoprazole
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heartburn focused on measuring Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Consultants Inc.
  • Radiant Research
  • California Bio Medical Research Institute
  • Allergy Medical Group of North Area
  • Eastern Research
  • Health Awareness Inc.
  • Miami Research Associates
  • Radiant Research
  • Radiant Research
  • Clinical Associates
  • Medex Healthcare Research, Inc.
  • Meridian Clinical Research LLC
  • William W. Anderson M.D. P.C.
  • IRSI
  • Crescent Medical Research
  • Micheal Alexander, DO
  • New Hope Research of Oregon
  • Preferred Primary Care Physicians
  • Advanced Therapeutics, Inc
  • Nashville Medical Research
  • Medical Edge Healthcare Group, P.A.
  • Benchmark Research
  • Benchmark Research
  • Commonwealth Clinical Research Specialist
  • National Clinical Research Inc.
  • Radiant Research

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
October 18, 2006
Last Updated
April 13, 2007
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00389948
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn
Keywords
Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
576 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lanzoprazole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
Title
To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
Title
Evaluation of lansoprazole safety.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Experiencing heartburn at least 2 days per week 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 or exclusion criteria may apply
Facility Information:
Facility Name
Clinical Research Consultants Inc.
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Radiant Research
City
Sierra Vista
State/Province
Arizona
ZIP/Postal Code
85635
Country
United States
Facility Name
California Bio Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Allergy Medical Group of North Area
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
Eastern Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Health Awareness Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Radiant Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30252
Country
United States
Facility Name
Radiant Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Clinical Associates
City
Reisterstown
State/Province
Maryland
ZIP/Postal Code
21136
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
William W. Anderson M.D. P.C.
City
Rio Rancho
State/Province
New Mexico
ZIP/Postal Code
87124
Country
United States
Facility Name
IRSI
City
Port Chester
State/Province
New York
ZIP/Postal Code
10573
Country
United States
Facility Name
Crescent Medical Research
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Micheal Alexander, DO
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43204
Country
United States
Facility Name
New Hope Research of Oregon
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Carnegie
State/Province
Pennsylvania
ZIP/Postal Code
15106
Country
United States
Facility Name
Advanced Therapeutics, Inc
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Nashville Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Medical Edge Healthcare Group, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Benchmark Research
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Commonwealth Clinical Research Specialist
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
National Clinical Research Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Radiant Research
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States

12. IPD Sharing Statement

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Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

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