Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

Takeda

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux

Treatments: Drug: Lansoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135368

U1111-1115-1139 (Registry Identifier)

AGO K019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 506 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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506 participants in 1 patient group

Lansoprazole

Experimental group

Description:

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.

Treatment:

Drug: Lansoprazole