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Search / Trial NCT01135368

Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

Launched by TAKEDA · Jun 1, 2010

Trial Information

Current as of July 21, 2025

Completed

Keywords

Gerd Gastroesophageal Reflux Disease Drug Therapy

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • 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.

About Takeda

Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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