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Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

NCT ID: NCT01135368

Last Updated: 2012-09-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2008-09-30

Brief Summary

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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

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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

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Gastroesophageal Reflux

Keywords

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GERD Gastroesophageal Reflux Disease Drug Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.

Group Type EXPERIMENTAL

Lansoprazole

Intervention Type DRUG

Lansoprazole capsules

Interventions

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Lansoprazole

Lansoprazole capsules

Intervention Type DRUG

Other Intervention Names

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Prevacid Helicid Zoton Inhibitol Agopton AG-1749

Eligibility Criteria

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Inclusion Criteria

* Had Gastro Esophageal Reflux disease with or without oesophagitis.
* Had a history of heartburn at least for 5 days per week during the past 6 months or was receiving long-term treatment with a proton pump inhibitor and during two weeks (without proton pump inhibitor treatment) prior to enrolment.

Exclusion Criteria

* History of surgery of stomach or oesophagus.
* Gastric ulcer (can be included after healing of gastric ulcer).
* Duodenal ulcer (can be included after healing of duodenal ulcer).
* Bleeding (melena, hematemesis).
* Severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases).
* Barrett oesophagus with dysplasia.
* Complicated esophagitis (oesophageal strictures or ulcers).
* Treatment with proton pump inhibitor or Histamine receptor 2 (H2)antagonists within the previous two weeks.
* Pregnancy, wish to become pregnant, breast feeding.
* Treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic acid (aspirin) \> 100 mg/day.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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U1111-1115-1139

Identifier Type: REGISTRY

Identifier Source: secondary_id

AGO K019

Identifier Type: -

Identifier Source: org_study_id