Gastroesophageal RefluxPhase 4NCT01135368
Safety and Efficacy of Lansoprazole in Patients With Reflux Disease
A Phase 4 study testing Lansoprazole in people with Gastroesophageal Reflux, run by Takeda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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 this study
Official title: Safety and Efficacy of Lansoprazole in Patients With Reflux Disease. An Open, Single Arm, Long-term Study
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Lansoprazole
- Keywords
- GERD, Gastroesophageal Reflux Disease, Drug Therapy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Also called Prevacid, Helicid, Zoton, Inhibitol
Lansoprazole capsules
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole | Experimental | 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. Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Reflux Disease Symptom - Heartburn
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.
Measured: Baseline and Week 8
Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation
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.
Measured: Baseline and Week 8
Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing
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.
Measured: Baseline and Week 8
Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen
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.
Measured: Baseline and Week 8
Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting
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.
Measured: Baseline and Week 8
Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat
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.
Measured: Baseline and Week 8
Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy
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).
Measured: Baseline and Week 8
Secondary outcomes (29)
Change From Baseline in Enterochromaffin-like Cell Hyperplasia
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.
Measured: Baseline and Year 5
Change From Baseline in Antrum Atrophy
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).
Measured: Baseline and Year 5
Change From Baseline in Corpus Atrophy
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).
Measured: Baseline and Year 5
Change From Baseline in Average Antrum Chronic Inflammation Score
Chronic inflammation of the antrum was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe
Measured: Baseline and Year 5
Change From Baseline in Corpus Chronic Inflammation Score
Chronic inflammation of the corpus was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe.
Measured: Baseline and Year 5
Change From Baseline in Antrum Intestinal Metaplasia
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).
Measured: Baseline and Year 5
Change From Baseline in Corpus Intestinal Metaplasia
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).
Measured: Baseline and Year 5
Change From Baseline in Blood Analysis - Testosterone
The change between testosterone measured at year 5 in males including final visit and Testosterone measured at baseline.
Measured: Baseline and Year 5
Change From Baseline in Blood Analysis - Luteinizing Hormone
The change between luteinizing hormone measured at year 5 in males including final visit and luteinizing hormone measured at baseline.
Measured: Baseline and Year 5
Change From Baseline in Blood Analysis - Follicle Stimulating Hormone
The change between follicle stimulating hormone (FSH) measured at year 5 in males including final visit and follicle stimulating hormone measured at baseline.
Measured: Baseline and Year 5.
Ophthalmologic Examination - Visual Acuity
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.
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Adaptation With Glare
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Accommodation
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Color Vision
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye
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).
Measured: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye
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).
Measured: Baseline and Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJun 2002
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135368
- Sponsor's protocol ID
- AGO K019
- Other IDs
- U1111-1115-1139
- Status last verified
- Jul 2012
- First submitted
- 1 Jun 2010
- Last updated
- 3 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lansoprazole in Patients With Reflux Disease. An Open, Single Arm, Long-term Study
- ClinicalTrials.gov ID
- NCT01135368
- Acronym / sponsor ID
- AGO K019
- Conditions
- Gastroesophageal Reflux
- Keywords
- GERD, Gastroesophageal Reflux Disease, Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Posted 3 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole | Experimental | Drug: LansoprazoleLansoprazole 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LansoprazoleAlso: Prevacid, Helicid, Zoton, InhibitolLansoprazole capsules | Drug | Lansoprazole |
Primary outcome
Change From Baseline in Reflux Disease Symptom - Heartburn
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
29 secondary outcomes
Change From Baseline in Enterochromaffin-like Cell Hyperplasia
Time frame: Baseline and Year 5
Change From Baseline in Antrum Atrophy
Time frame: Baseline and Year 5
Change From Baseline in Corpus Atrophy
Time frame: Baseline and Year 5
Change From Baseline in Average Antrum Chronic Inflammation Score
Time frame: Baseline and Year 5
Change From Baseline in Corpus Chronic Inflammation Score
Time frame: Baseline and Year 5
Change From Baseline in Antrum Intestinal Metaplasia
Time frame: Baseline and Year 5
Change From Baseline in Corpus Intestinal Metaplasia
Time frame: Baseline and Year 5
Change From Baseline in Blood Analysis - Testosterone
Time frame: Baseline and Year 5
Change From Baseline in Blood Analysis - Luteinizing Hormone
Time frame: Baseline and Year 5
Change From Baseline in Blood Analysis - Follicle Stimulating Hormone
Time frame: Baseline and Year 5.
Ophthalmologic Examination - Visual Acuity
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Adaptation With Glare
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Accommodation
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Color Vision
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye
Time frame: Baseline and Year 5
Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye
Time frame: Baseline and Year 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole in people with Gastroesophageal Reflux, run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Reflux Disease Symptom - Heartburn (time frame: Baseline and Week 8). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.