Clinical trial NCT01135368: Safety and Efficacy of Lansoprazole in Patients With Reflux Disease
Official title: Safety and Efficacy of Lansoprazole in Patients With Reflux Disease. An Open, Single Arm, Long-term Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux
Keywords: GERD
Gastroesophageal Reflux Disease
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Change From Baseline in Reflux Disease Symptom - Heartburn
timeFrame: Baseline and Week 8
measure: Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation
timeFrame: Baseline and Week 8
measure: Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing
timeFrame: Baseline and Week 8
measure: Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen
timeFrame: Baseline and Week 8
measure: Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting
timeFrame: Baseline and Week 8
measure: Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat
timeFrame: Baseline and Week 8
measure: Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change From Baseline in Enterochromaffin-like Cell Hyperplasia
timeFrame: Baseline and Year 5
measure: Change From Baseline in Antrum Atrophy
timeFrame: Baseline and Year 5
measure: Change From Baseline in Corpus Atrophy
timeFrame: Baseline and Year 5
measure: Change From Baseline in Average Antrum Chronic Inflammation Score
timeFrame: Baseline and Year 5
measure: Change From Baseline in Corpus Chronic Inflammation Score
timeFrame: Baseline and Year 5
measure: Change From Baseline in Antrum Intestinal Metaplasia
timeFrame: Baseline and Year 5
measure: Change From Baseline in Corpus Intestinal Metaplasia
timeFrame: Baseline and Year 5
measure: Change From Baseline in Blood Analysis - Testosterone
timeFrame: Baseline and Year 5
measure: Change From Baseline in Blood Analysis - Luteinizing Hormone
timeFrame: Baseline and Year 5
measure: Change From Baseline in Blood Analysis - Follicle Stimulating Hormone
timeFrame: Baseline and Year 5.
measure: Ophthalmologic Examination - Visual Acuity
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Adaptation With Glare
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Accommodation
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Color Vision
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye
timeFrame: Baseline and Year 5
measure: Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye
timeFrame: Baseline and Year 5
Other outcomes:
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