2024-516667-91-00招募中4 期
The effect of oral buspirone hydrochloride on esophageal motility, bolus transit and symptoms of dysphagia, in patients with poor esophageal motility: A randomized, double-blind, placebo controlled, cross-over trial with high resolution esophageal manometry and impedance.
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in distal contractile integral (DCI, mm Hg*s*cm) between buspirone and placebo established on high resolution impedance manometry (HRiM), for the liquid bolus (5 mL) in supine position.
研究概览
简要总结
To investigate the effect of buspirone on high-resolution manometry parameters (specifically: distal contractile integral, DCI) in patients with poor esophageal motility during a high resolution impedance manometry with 3 types of boluses (on liquid bolus, 5mL, in supine position)
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
- •Ineffective motility or absent contractility identified on HRiM
- •Primary complaint of dysphagia for a minimum of 2 months
- •Age > 18 years
- •No anatomical cause for symptoms
- •No hiatal hernia ≥3 cm
- •Sexually active women of childbearing potential participating in the study must be using an appropriate form of contraception.
排除标准
- •Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed off PPI treatment in the 12 months prior to screening, or ≥ grade B when endoscopy is performed during PPI treatment.
- •Major psychiatric disorder.
- •Pregnancy or breastfeeding.
- •History of poor compliance.
- •History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
- •History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
- •Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis)
- •Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
- •Hiatal hernia ≥3 cm
- •QT c>450 ms.
- •Use of medication that effect cholinergic function such as anticholinergics, tricyclic antidepressants.
- •Concomitant promotility agents such as prucalopride or domperidone.
- •Concomitant use of more than one benzodiazepine.
- •Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
结局指标
主要结局
Change in distal contractile integral (DCI, mm Hg*s*cm) between buspirone and placebo established on high resolution impedance manometry (HRiM), for the liquid bolus (5 mL) in supine position.
Change in distal contractile integral (DCI, mm Hg*s*cm) between buspirone and placebo established on high resolution impedance manometry (HRiM), for the liquid bolus (5 mL) in supine position.
次要结局
- Change in symptoms between placebo and buspirone during the HRiM with 3 types of boluses: A Likert score applied during all swallows: 1 (Normal), 2 (Slow passage of bolus), 3 (Stepwise passage), 4 (Partial Blockage), 5 (Complete Blockage)
- Proximal Contractile Integral (PCI es., mmHg.s.cm)
- Distal Contractile Integral (DCI, mmHg.s.cm)
- Largest Break Size (cm)
- Distal Latency (DL, s)
- Integrated Relaxation Pressure 4s (IRP4s, mmHg)
- Pressure Flow Index (PFI)
- Impedance Ratio (IR)
- Distension Pressure Accommodation (DPA, mmHg)
- Distension Pressure Emptying (DPE, mmHg)
- Ramp Pressure (RP, mmHg/s)
- Contractile Segment Impedance (CSI, Ohms)
- Bolus Presence Time (BPT, s)
- Bolus Flow Time (BFT, s)
- Esophago-Gastric Junction Resting Pressure (EGJ Rest.P, mmHg)
- Esophago-Gastric Junction Contractile Integral (EGJCI, mmHg.cm)
- Lower Esophageal Sphincter – Crural Diaphragm (LES-CD, mm)
- Mayo Dysphagia Questionnaire
- Overall Treatment Evaluation
- Overall Symptom Severity
研究者
Jan Tack
Scientific
UZ Leuven
研究点 (1)
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