Safety and Efficacy of Lansoprazole in Patients With Reflux Disease
- Registration Number
- NCT01135368
- Lead Sponsor
- Takeda
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 506
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lansoprazole 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Reflux Disease Symptom - Heartburn Baseline and Week 8 Heartburn symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation Baseline and Week 8 Acid regurgitation symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing Baseline and Week 8 Difficulty swallowing symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen Baseline and Week 8 Pain in the upper abdomen symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting Baseline and Week 8 Nausea and vomiting symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat Baseline and Week 8 Cough and sore throat symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy Baseline and Week 8 Los Angeles Classification is used to grade the extension of changes in the oesophagus induced by reflux disease (Grade 0: normal aspect of mucosa; Grade A: ≥1 mucosal breaks no longer than 5 mm; Grade B: ≥1 mucosal breaks \>5 mm long; Grade C: mucosal breaks extending between tops of two or more mucosal folds but are \<75% of the circumference; Grade D: mucosal breaks ≥75% of the circumference). Healed defined as anything less than Grade A criteria. The shift table below summarizes the individual transitions in Los Angeles classification between Baseline (table columns) and Week 8 (table rows).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Enterochromaffin-like Cell Hyperplasia Baseline and Year 5 Enterochromaffin-like (ECL) cells were evaluated and classified by histopathological examinations as Normal, Simple (diffuse) hyperplasia, or Linear, chain producing hyperplasia.
The shift table below summarizes the individual transitions in ECL-cell classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows) for all patients.Change From Baseline in Antrum Atrophy Baseline and Year 5 Atrophy was assessed by histopathological examination of cells biopsied from the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Corpus Atrophy Baseline and Year 5 Atrophy was assessed by histopathological examination of cells biopsied from the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Average Antrum Chronic Inflammation Score Baseline and Year 5 Chronic inflammation of the antrum was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe
Change From Baseline in Corpus Chronic Inflammation Score Baseline and Year 5 Chronic inflammation of the corpus was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe.
Change From Baseline in Antrum Intestinal Metaplasia Baseline and Year 5 Intestinal metaplasia was assessed by biopsy and histopathological examination of the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Corpus Intestinal Metaplasia Baseline and Year 5 Intestinal metaplasia was assessed by biopsy and histopathological examination of the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Blood Analysis - Testosterone Baseline and Year 5 The change between testosterone measured at year 5 in males including final visit and Testosterone measured at baseline.
Change From Baseline in Blood Analysis - Luteinizing Hormone Baseline and Year 5 The change between luteinizing hormone measured at year 5 in males including final visit and luteinizing hormone measured at baseline.
Change From Baseline in Blood Analysis - Follicle Stimulating Hormone Baseline and Year 5. The change between follicle stimulating hormone (FSH) measured at year 5 in males including final visit and follicle stimulating hormone measured at baseline.
Ophthalmologic Examination - Visual Acuity Baseline and Year 5 Visual Acuity was measured using the Snellen eye chart at a distance of 6 meters. Acuity is expressed as a ratio of the test distance (6 M) / the distance the average eye can see the letters on a certain line of the eye chart. Visual acuity of 1 is normal; an individual with acuity of 0.5 could only recognize an object at half the distance compared to an individual with normal acuity.
Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare Baseline and Year 5 Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation without glare was defined as follows:
* Normal status: Contrast between 1:0.05 and 1:23.5.
* Pathological status: Contrast = 0 or contrast \> 1:23.5.
The shift table below summarizes the individual transitions in the classification of adaptation without glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows).Change From Baseline in Ophthalmologic Examination - Adaptation With Glare Baseline and Year 5 Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation with glare was defined as follows:
* Normal status: Contrast between 1:0.05 and 1:23.5.
* Pathological status: Contrast = 0 or contrast \> 1:23.5.
The shift table below summarizes the individual transitions in the classification of adaptation with glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows).Change From Baseline in Ophthalmologic Examination - Accommodation Baseline and Year 5 Accommodation is the adjustment of the focal length of the eye lens to keep an object in focus on the retina as its distance from the eye varies, and is measured in diopters: Diopters = 1/(focal length).
Change From Baseline in Ophthalmologic Examination - Color Vision Baseline and Year 5 Color vision was assessed by an Ophthalmologist and classified as normal or pathological. Pathological findings include abnormal color vision tests, color blindness and anomalous quotient. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in color vision classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye Baseline and Year 5 The cornea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye Baseline and Year 5 The cornea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye Baseline and Year 5 The lens of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.
Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye Baseline and Year 5 The lens of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.
Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye Baseline and Year 5 The vitreous body of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.
Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye Baseline and Year 5 The vitreous body of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.
Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye Baseline and Year 5 The retinal aspect of the right eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye Baseline and Year 5 The retinal aspect of the left eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye Baseline and Year 5 The optic nerve and papilla of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye Baseline and Year 5 The optic nerve and papilla of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye Baseline and Year 5 The retinal blood vessels of the right eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye Baseline and Year 5 The retinal blood vessels of the left eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye Baseline and Year 5 The macula lutea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye Baseline and Year 5 The macula lutea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).