A Study of Efficacy and Safety of "on-Demand" Maintenance Therapy With Rabeprazole in Patients With Non-Erosive Reflux Disease (NERD) - Full Text View

Sponsored by:	Janssen Pharmaceutica N.V., Belgium
Information provided by:	Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:	NCT00236392

Purpose

The purpose of this study is to assess the efficacy and safety of long-term, "on-demand" maintenance therapy with rabeprazole in patients with non-erosive reflux disease (NERD).

Condition	Intervention	Phase
Heartburn Gastroesophageal Reflux	Drug: rabeprazole	Phase III

MedlinePlus related topics: GERD Heartburn

Drug Information available for: E 3810

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind Placebo-Controlled Randomized Withdrawal Trial Assessing the Efficacy and Tolerability of "On-Demand" Maintenance Therapy With 10mg o.d. Rabeprazole for 6 Months in Non-Erosive Reflux Disease Patients With Complete Symptom Relief After 4 Week Open Acute Phase

Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:

Proportion of patients discontinuing treatment in "on-demand" phase (6 months) because of insufficient heartburn control.

Secondary Outcome Measures:

Severity and control of heartburn, overall quality of life (Psychological General Well-Being Index), antacid consumption, and patient satisfaction at the beginning and end of the "on-demand" phase. Incidence of adverse events throughout study

Estimated Enrollment:	500
Study Start Date:	July 2001
Estimated Study Completion Date:	October 2002

Detailed Description:

More than half of patients with typical gastroesophageal reflux symptoms such as heartburn are considered to have non-erosive reflux disease (NERD), which is characterized by a lack of clinically defined damage to the esophagus. One approach to maintain control of these syptoms is to have medication available "on-demand." This is a double-blind, placebo-controlled study of the effectiveness of "on-demand" rabeprazole in the long-term maintenance of hearburn control in NERD patients, for whom heartburn was resolved with short-term, daily rabeprazole therapy. The study has two phases: an acute phase (4 weeks) during which patients receive rabeprazole medication daily, and an "on-demand" phase (6 months) during which patients take medication (rabeprazole or placebo) as needed. Only patients who have complete resolution of heartburn at the end of the acute phase are eligible to continue in the "on-demand" phase. Efficacy assessments include the proportion of patients discontinuing treatment in the "on-demand" phase because of insufficient heartburn control, and the severity of heartburn and patient satisfaction determined at the beginning and end of "on-demand" phase. Safety assessments include incidence of adverse events throughout the study, physical examination at study initiation, and vital signs at the beginning and the end of the study. The study hypothesis is that "on-demand" therapy with rabeprazole is superior to placebo in maintaining heartburn control and is well tolerated by the patients with NERD.

Rabeprazole tablet (10 milligrams[mg]) once daily in the morning for 4 weeks. Rabeprazole tablets (10mg) once daily on an "on-demand" basis for the following 6 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Minimum of 12 months history of heartburn as the predominant symptom with at least 2 symptomatic episodes
Negative endoscopy (no erosive lesions according to the Modified Savary-Miller scale) within 7 days prior to acute treatment
At least 3 days with moderate to very severe heartburn within one week prior to acute treatment

Exclusion Criteria:

No known gastro-duodenal ulcer - No infections, inflammations, or obstruction of the small or large intestine
No history of gastrointestinal cancer, or prior surgery of the stomach or intestine
No stomach or abdominal pain or discomfort as the predominant symptom or that requires treatment
No history of erosive reflux causing inflammation of the esophagus
No stricture of the esophagus, stomach, or any condition that causes difficulty in swallowing
No history of non-erosive reflux disease (NERD) that is or was refractory to an adequate treatment course (1 month) with proton pump inhibitors
No females who are pregnant or those lacking adequate contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236392

Sponsors and Collaborators

Janssen Pharmaceutica N.V., Belgium

Investigators

Study Director:

Janssen Pharmaceutica N.V. Clinical Trial

Janssen Pharmaceutica N.V., Belgium

More Information

Publications of Results:

Bytzer P, Blum A, De Herdt D, Dubois D; The Trial Investigators. Six-month trial of on-demand rabeprazole 10 mg maintains symptom relief in patients with non-erosive reflux disease. Aliment Pharmacol Ther. 2004 Jul 15;20(2):181-8.

Study ID Numbers:	CR003121
Study First Received:	October 7, 2005
Last Updated:	April 6, 2007
ClinicalTrials.gov Identifier:	NCT00236392
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:

GORD
Proton pump inhibitor
Rabeprazole
Heartburn
NERD

Non-Erosive Reflux Disease
Gastroesophageal reflux
GERD
Anti-ulcer agents

Study placed in the following topic categories:

Pyrosis
Signs and Symptoms, Digestive
Esophageal disorder
Gastrointestinal Diseases
Ulcer
Gastroesophageal Reflux
Esophageal Motility Disorders

Deglutition Disorders
Signs and Symptoms
Digestive System Diseases
Heartburn
Esophageal Diseases
Rabeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009