Trial · NCT01135368
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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