2023-510195-31-00招募中2 期
Double-blind, randomised, placebo-controlled, dose-finding phase IIb trial to evaluate the efficacy, safety, and tolerability of a 12-week-treatment with Naronapride in adult participants with at least moderate idiopathic or diabetic gastroparesis
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 46
- 主要终点
- Change of the average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)
研究概览
简要总结
To evaluate the efficacy of a 12-week treatment with naronapride compared to placebo on disease signs and symptoms in participants with at least moderate idiopathic or diabetic gastroparesis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Men and women between ≥18 and ≤75 years of age
- •History of idiopathic or diabetic gastroparesis cardinal symptoms for ≥ 3 months
- •Evidence of delayed gastric emptying
- •Average weekly total symptom score of ≥2.0
- •Body Mass Index ≥16 and <35 kg/m2
- •Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging technique
排除标准
- •Participants without access to an internet-capable terminal and/or without an own e-mail address
- •History of major gastrointestinal surgery
- •Intrapyloric botulinum toxin injection within 12 months
- •Active gastric stimulator implant
- •Known secondary causes of gastroparesis
- •Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis
结局指标
主要结局
Change of the average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)
Change of the average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)
次要结局
- Change of the modified and composite average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)
- Change of the average weekly symptom score for nausea/early satiety/postprandial fullness/upper abdominal pain/number of vomiting episodes/bloating from BSL to EOT/WD
研究者
CTIS – Scientific Request
Scientific
Dr. Falk Pharma GmbH
研究点 (46)
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