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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
History of Changes
  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:

MedlinePlus related topics: Heartburn
U.S. FDA Resources

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

  Show 30 Study Locations
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
Proton Pump Inhibitors
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013