NCT00701259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
852

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

First QC Date

June 17, 2008

Last Update Submit

January 13, 2010

Conditions

Frequent Heartburn

Keywords

Frequent heartburn, proton pump inhibitor, lansoprazoleTreatment ofover 14 days

Outcome Measures

Primary Outcomes (1)

  • Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.

    14 days

Secondary Outcomes (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.

    14 days

Study Arms (3)

1

EXPERIMENTAL

15 mg lansoprazole

Drug: Lansoprazole

2

EXPERIMENTAL

30 mg lansoprazole

Drug: Lansoprazole

3

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

LansoprazoleDRUG

Lansoprazole 15 mg once per day for 14 days

Also known as: Prevacid - United States
1
placeboDRUG
3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing heartburn at least 2 days per week during the nighttime period over the past month.
  • Having heartburn that responds to heartburn medication.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Not applicable - enrollment complete

Parsippany, New Jersey, 07054, United States

Location

MeSH Terms

Interventions

Lansoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

January 1, 2007

Study Completion

August 1, 2007

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(1)