Clinical Trials Directory

Trials / Completed

CompletedNCT01135368

Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

Safety and Efficacy of Lansoprazole in Patients With Reflux Disease. An Open, Single Arm, Long-term Study

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
506 (actual)
Sponsor
Takeda · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to measure the safety, efficacy and quality of life of lansoprazole in patients with reflux disease over a five year period.

Detailed description

Lansoprazole is currently approved in Germany for the treatment of erosive reflux esophagitis and active duodenal and gastric ulcer disease, and for long-term treatment including maintenance of healed reflux esophagitis and duodenal ulcer disease and treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome. This study was conducted to evaluate the safety, efficacy and quality of life of patients receiving up to five years of treatment with lansoprazole.

Conditions

Interventions

TypeNameDescription
DRUGLansoprazoleLansoprazole capsules

Timeline

Start date
2002-06-01
Primary completion
2008-09-01
Completion
2008-09-01
First posted
2010-06-02
Last updated
2012-09-03
Results posted
2012-09-03

Source: ClinicalTrials.gov record NCT01135368. Inclusion in this directory is not an endorsement.