Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00701259

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 III

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

Resource links provided by NLM:

MedlinePlus related topics: Heartburn

Drug Information available for: Lansoprazole

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
1: Experimental 15 mg lansoprazole	Drug: Lansoprazole Lansoprazole 15 mg once per day for 14 days
2: Experimental 30 mg lansoprazole	Drug: Lansoprazole Lansoprazole 30 mg once per day for 14 days
3: Placebo Comparator 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:	Novartis ( Donna Coughlin: Regulatory Affairs )
Study ID Numbers:	PRSW-GN-305
Study First Received:	June 17, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00701259 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Frequent heartburn, proton pump inhibitor, lansoprazole
Treatment of
over 14 days

Study placed in the following topic categories:

Signs and Symptoms
Pyrosis
Proton Pump Inhibitors

Signs and Symptoms, Digestive
Heartburn
Lansoprazole

Additional relevant MeSH terms:

Anti-Infective Agents
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Heartburn
Enzyme Inhibitors
Lansoprazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009