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Sponsored by: |
Novartis |
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00701259 |
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 III |
MedlinePlus related topics: | Heartburn |
Drug Information available for: | Lansoprazole |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 852 |
Study Start Date: | January 2007 |
Study Completion Date: | August 2007 |
Arms | Assigned Interventions |
1: Experimental
15 mg lansoprazole
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Drug: Lansoprazole
Lansoprazole 15 mg once per day for 14 days
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2: Experimental
30 mg lansoprazole
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Drug: Lansoprazole
Lansoprazole 30 mg once per day for 14 days
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3: Placebo Comparator
placebo
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Drug: placebo |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
"Other protocol-defined inclusion/exclusion criteria may apply"
Responsible Party: | Novartis ( Donna Coughlin: Regulatory Affairs ) |
Study ID Numbers: | PRSW-GN-305 |
First Received: | June 17, 2008 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00701259 |
Health Authority: | United States: Food and Drug Administration |
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