Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00390390
Collaborator
(none)
576
30
7
19.2
2.7
Study Details
Study Description
Brief Summary
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn
Study Start Date
:
Jun 1, 2006
Actual Study Completion Date
:
Jan 1, 2007
Outcome Measures
Primary Outcome Measures
- To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo. []
Secondary Outcome Measures
- To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo []
- To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo []
- Evaluation of lansoprazole safety. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Experiencing heartburn at least 2 days per week 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 or exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunbelt Research Group | Mobile | Alabama | United States | 36608 |
| 2 | Arkansas Primary Care Clinic | Little Rock | Alaska | United States | 72204 |
| 3 | Radiant Research | Chandler | Arizona | United States | 85225 |
| 4 | Radiant Research - Scottsdale | Scottsdale | Arizona | United States | 85251 |
| 5 | Edinger Medical Group | Fountain Valley | California | United States | 92709 |
| 6 | Gaslamp Medical Center | San Diego | California | United States | 92101 |
| 7 | Expresscare Clinical Research | Colorado Springs | Colorado | United States | 80909 |
| 8 | Central Florida Clinical Trials inc. | Altamonte Springs | Florida | United States | 32714 |
| 9 | Tampa Bay Medical Research, Inc. | Clearwater | Florida | United States | 33761 |
| 10 | Health Awareness Inc. | Jupiter | Florida | United States | 33458 |
| 11 | University Clinical Research, Inc. | Pembroke Pines | Florida | United States | 33024 |
| 12 | Palm Beach Research | West Palm Beach | Florida | United States | 33409 |
| 13 | Accelovance | Peoria | Illinois | United States | 61602 |
| 14 | IRSI | Rockland | Massachusetts | United States | 04841 |
| 15 | Prime Care Research | St. Louis | Missouri | United States | 63031 |
| 16 | Clinical Research Center of Nevada | Las Vegas | Nevada | United States | 89104 |
| 17 | Urgentmed | South Bound Brook | New Jersey | United States | 08880 |
| 18 | Wake research associates, Inc | Raleigh | North Carolina | United States | 27612 |
| 19 | Piedmont Medical Research | Winston Salem | North Carolina | United States | 27103 |
| 20 | Radiant Research | Cincinnati | Ohio | United States | 45236 |
| 21 | Wells Institute For Health Awareness | Kettering | Ohio | United States | 45429 |
| 22 | Toledo Center for Clinical Research | Sylvania | Ohio | United States | 43560 |
| 23 | Durham Physicans | Durham | Pennsylvania | United States | 19047 |
| 24 | 2222 State Street | Nashville | Tennessee | United States | 37203 |
| 25 | Wells Branch Medical Center | Austin | Texas | United States | 78728 |
| 26 | Medical Edge Healthcare Group | Dallas | Texas | United States | 75243 |
| 27 | Houston | Texas | United States | 77002 | |
| 28 | Clinical Trials Network | Houston | Texas | United States | 77074 |
| 29 | Health Research of Hampton Roads | Newport News | Virginia | United States | 23606 |
| 30 | Holston Medical Group | Weber City | Virginia | United States | 24290 |
Sponsors and Collaborators
- Novartis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00390390
Other Study ID Numbers:
- PRSW-GN-302
First Posted:
Oct 19, 2006
Last Update Posted:
May 25, 2010
Last Verified:
Apr 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: