Clinical Trials Logo
  1. Home
  2. Heartburn
  3. NCT00389948
  4. Details
NCT00389948 Clinical Trial

Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Heartburn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00389948
Other study ID # PRSW-GN-301
Secondary ID
Status Completed
Phase Phase 3
First received October 18, 2006
Last updated April 13, 2007
Start date June 2006
Est. completion date January 2007

Study information
Verified date April 2007
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 576
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Experiencing heartburn at least 2 days per week over the past month.

2. Having heartburn that responds to heartburn medication.

3. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion Criteria:

1. Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).

2. 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lanzoprazole

Locations
Country Name City State
United States Radiant Research Atlanta Georgia
United States Radiant Research Atlanta Georgia
United States Preferred Primary Care Physicians Carnegie Pennsylvania
United States Micheal Alexander, DO Columbus Ohio
United States Medical Edge Healthcare Group, P.A. Dallas Texas
United States Benchmark Research Fort Worth Texas
United States Eastern Research Hialeah Florida
United States Clinical Research Consultants Inc. Hoover Alabama
United States Advanced Therapeutics, Inc Johnson City Tennessee
United States Health Awareness Inc. Jupiter Florida
United States Radiant Research Lakewood Washington
United States California Bio Medical Research Institute Los Angeles California
United States Miami Research Associates Miami Florida
United States Nashville Medical Research Nashville Tennessee
United States Meridian Clinical Research LLC Omaha Nebraska
United States IRSI Port Chester New York
United States New Hope Research of Oregon Portland Oregon
United States Clinical Associates Reisterstown Maryland
United States Commonwealth Clinical Research Specialist Richmond Virginia
United States National Clinical Research Inc. Richmond Virginia
United States William W. Anderson M.D. P.C. Rio Rancho New Mexico
United States Allergy Medical Group of North Area Roseville California
United States Crescent Medical Research Salisbury North Carolina
United States Benchmark Research San Angelo Texas
United States Radiant Research Sierra Vista Arizona
United States Medex Healthcare Research, Inc. St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
Secondary To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
Secondary Evaluation of lansoprazole safety.
See also
  Status Clinical Trial Phase
Recruiting NCT06094062 - Smartphone App-assisted PPI N/A
Completed NCT00481949 - Assessment of Gastro-esophageal Reflux Using Endo-Flip vs Bravo N/A
Completed NCT04560595 - Remote Guided Caffeine Reduction N/A
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3
Recruiting NCT02105090 - Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy Phase 4
Completed NCT01338077 - Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease Phase 3
Completed NCT01005251 - Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI Phase 2
Terminated NCT00536328 - What is the Predictive Value of the Reflux Impact Scale N/A
Completed NCT00382577 - Efficacy and Safety of Itopride vs Placebo in Heartburn Phase 3
Completed NCT00236197 - E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers Phase 3
Completed NCT00236184 - E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers Phase 3
Completed NCT00236392 - A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD) Phase 3
Completed NCT04153552 - Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn N/A
Recruiting NCT06075082 - The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms. N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Recruiting NCT02277886 - Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances Phase 4
Completed NCT01249651 - To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole Phase 4
Completed NCT00588939 - Confocal Laser Microscopy in Non Erosive Reflux Disease N/A
Completed NCT00206024 - Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Phase 4
Recruiting NCT05976165 - A Study of Breath Testing for Small Intestinal Bacterial Overgrowth N/A