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Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00701259
First received: June 17, 2008
Last updated: January 13, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
Frequent Heartburn
 Drug: Lansoprazole
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Heartburn
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 852
Study Start Date: January 2007
Study Completion Date: August 2007
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701259

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

No publications provided

Responsible Party: Regulatory Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00701259     History of Changes
Other Study ID Numbers: PRSW-GN-305
Study First Received: June 17, 2008
Last Updated: January 13, 2010
Health Authority: United States: Food and Drug Administration

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
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