Status:
COMPLETED
Safety and Efficacy of Lansoprazole in Patients With Reflux Disease
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT01135368
Start Date
June 1 2002
End Date
September 1 2008
Last Update
September 3 2012
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