We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00390390
First Posted: October 19, 2006
Last Update Posted: May 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390390


  Show 30 Study Locations
Sponsors and Collaborators
Novartis
  More Information

ClinicalTrials.gov Identifier: NCT00390390     History of Changes
Other Study ID Numbers: PRSW-GN-302
First Submitted: October 18, 2006
First Posted: October 19, 2006
Last Update Posted: May 25, 2010
Last Verified: April 2007

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
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action