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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
Lansoprazole
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

  • Sunbelt Research Group
  • Arkansas Primary Care Clinic
  • Radiant Research
  • Radiant Research - Scottsdale
  • Edinger Medical Group
  • Gaslamp Medical Center
  • Expresscare Clinical Research
  • Central Florida Clinical Trials inc.
  • Tampa Bay Medical Research, Inc.
  • Health Awareness Inc.
  • University Clinical Research, Inc.
  • Palm Beach Research
  • Accelovance
  • IRSI
  • Prime Care Research
  • Clinical Research Center of Nevada
  • Urgentmed
  • Wake research associates, Inc
  • Piedmont Medical Research
  • Radiant Research
  • Wells Institute For Health Awareness
  • Toledo Center for Clinical Research
  • Durham Physicans
  • 2222 State Street
  • Wells Branch Medical Center
  • Medical Edge Healthcare Group
  • Clinical Trials Network
  • Health Research of Hampton Roads
  • Holston Medical Group

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
May 24, 2010
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00390390
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)
Lansoprazole
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
Sunbelt Research Group
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arkansas Primary Care Clinic
City
Little Rock
State/Province
Alaska
ZIP/Postal Code
72204
Country
United States
Facility Name
Radiant Research
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Radiant Research - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Edinger Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92709
Country
United States
Facility Name
Gaslamp Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Expresscare Clinical Research
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Central Florida Clinical Trials inc.
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Facility Name
Tampa Bay Medical Research, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Health Awareness Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Palm Beach Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Accelovance
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
IRSI
City
Rockland
State/Province
Massachusetts
ZIP/Postal Code
04841
Country
United States
Facility Name
Prime Care Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Urgentmed
City
South Bound Brook
State/Province
New Jersey
ZIP/Postal Code
08880
Country
United States
Facility Name
Wake research associates, Inc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Piedmont Medical Research
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Wells Institute For Health Awareness
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Toledo Center for Clinical Research
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Durham Physicans
City
Durham
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
2222 State Street
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Wells Branch Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78728
Country
United States
Facility Name
Medical Edge Healthcare Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Clinical Trials Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Health Research of Hampton Roads
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Holston Medical Group
City
Weber City
State/Province
Virginia
ZIP/Postal Code
24290
Country
United States

12. IPD Sharing Statement

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Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

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