A Multicentric, Non-interventional Study on Switching From Oral Parkinson Therapy to Neupro® in Patients With Idiopathic Parkinson's Disease With Gastrointestinal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 21
- 主要终点
- Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)
研究概览
简要总结
The study intends to collect data on gastrointestinal symptoms (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient satisfaction under everyday practice conditions after changing treatment to Neupro® transdermal patch in patients suffering from idiopathic Parkinson´s Disease with gastrointestinal symptoms while being treated with oral antiparkinson drugs. The objective of the study is to ascertain whether switching therapy to Neupro® transdermal patch can provide any relief in gastrointestinal symptoms.
详细描述
Routine treatment as per approved label in Europe in accordance with the terms of the local marketing authorization for Neupro®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The decision to prescribe Neupro® must have been made by the physician before and independently of his/her decision to include the patient in the study
- •The patient's treatment must be in accordance with the terms of the local marketing authorization (MA) for Neupro®
- •The patient must have a diagnosis of Idiopathic Parkinson's disease
- •The patient must have signed the Consent form regarding study information, data transfer and use
- •Patient suffering from gastrointestinal symptoms while being treated with oral Parkinson's medication
排除标准
- •Not applicable
结局指标
主要结局
Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)
时间窗: From Baseline to Visit 3 (approximately 6 weeks)
Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.
Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints
时间窗: From Baseline to Visit 3 (approximately 6 weeks)
Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day). For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 - 12). Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 - 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2
时间窗: At Visit 2 (after approximately 2-4 weeks)
Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied.
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3
时间窗: At Visit 3 (after approximately 6 weeks)
Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied.
次要结局
未报告次要终点