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Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

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ClinicalTrials.gov Identifier: NCT00701259
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : January 15, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.

Condition or disease Intervention/treatment Phase
Frequent Heartburn Drug: Lansoprazole Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 852 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of Fourteen Day Treatment With Lansoprazole 15 mg or 30 mg Once a Day in Frequent Nighttime Heartburn
Study Start Date : January 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
15 mg lansoprazole
Drug: Lansoprazole
Lansoprazole 15 mg once per day for 14 days
Other Name: Prevacid - United States
Experimental: 2
30 mg lansoprazole
Drug: Lansoprazole
Lansoprazole 30 mg once per day for 14 days
Placebo Comparator: 3
placebo
Drug: placebo


Outcome Measures

Primary Outcome Measures :
  1. Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn. [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Proportion of 24 hour days with no heartburn during 14 days of treatment. Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose. The evaluation of lansoprazole safety. [ Time Frame: 14 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Experiencing heartburn at least 2 days per week during the nighttime period 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/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): NCT00701259


Locations
United States, New Jersey
Not applicable - enrollment complete
Parsippany, New Jersey, United States, 07054
Sponsors and Collaborators
Novartis
More Information

Responsible Party: Regulatory Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00701259     History of Changes
Other Study ID Numbers: PRSW-GN-305
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

Keywords provided by Novartis:
Frequent heartburn, proton pump inhibitor, lansoprazole
Treatment of
over 14 days

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