Efficacy/Safety of Lansoprazole in Patients With Frequent... | NCT00701259

Studies
Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

NCT00701259

Sponsor

Novartis

Status

Completed

Last Update Posted

Jan 15, 2010Estimated

Enrollment

852Actual

Phase

Phase 3

Conditions

Frequent Heartburn

Interventions

Lansoprazole
Lansoprazole
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Jun 17, 2008

First Submission Date that Met QC Criteria

Jun 18, 2008

First Posted Date

Jun 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2010

Last Update Posted Date

Jan 15, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

852Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	15 mg lansoprazole	Drug: Lansoprazole
2	Experimental	30 mg lansoprazole	Drug: Lansoprazole
3	Placebo Comparator	placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lansoprazole	Drug	Lansoprazole 15 mg once per day for 14 days	1	Prevacid - United States

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.		14 days

Secondary Outcomes

Measure	Description	Time Frame
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.		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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"

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Not applicable - enrollment complete		Parsippany	New Jersey	07054	United States

Intervention Browse Module

MeSH Terms

ID	Term
D064747	Lansoprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided