Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00390390
First received: October 18, 2006
Last updated: May 24, 2010
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Heartburn
Drug: Lansoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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.

Estimated Enrollment: 576
Study Start Date: June 2006
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390390

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

No publications provided

ClinicalTrials.gov Identifier: NCT00390390     History of Changes
Other Study ID Numbers: PRSW-GN-302
Study First Received: October 18, 2006
Last Updated: May 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014