NCT00414856已完成1 期
A Multi-Center, Randomized, Double-Blind, Placebo- and Positive-Control, Double-Dummy, 3 Parallel Cohort, Two-Way Crossover Single Oral Dose Study in GERD (Gastro Esophageal Reflux Disease) Patients to Evaluate the Effects of AFQ056 and Baclofen (Positive Control) on the Incidence of Meal-Induced Gastro Esophageal Reflux Events
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- Gastroesophageal reflux episodes as assessed by impedance measurements in the 4-hour period following a standardized high-fat meal in patients with GERD.
研究概览
简要总结
This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with GERD (18-60 years) with a history of moderate to severe reflux symptoms (heartburn or acid regurgitation more than 2 days/week, and/or night-time reflux, and/or after meal reflux) for ≥ 3 months with:
- •uncomplicated reflux-esophagitis of any degree as evidenced by esophagogastroduodenoscopy (EGD) within the last 12 months, OR (and) a pathological ambulatory 24-hours pH measurement within the last 12 months with pH < 4 for ≥ 9% of the time.
- •Females must be of no child bearing potential (postmenopausal women with no regular menstrual bleeding for at least 1 year or women who have been surgically sterilized at least 6 months prior). Menopause will be confirmed by a plasma FSH level of 37.0 - 185.0 mIU/mL. Surgical sterilization procedures must be supported with clinical documentation.
- •Patients must be able to completely finish the high-fat breakfast within 15 minutes.
- •Body mass index must be below
- •Patients must weigh at least 60 kg to participate in this study.
- •Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study and to understand and sign the written informed consent.
排除标准
- •History of:
- •Upper gastrointestinal (GI) surgery or radiation
- •GI disorders other than GERD that may significantly affect the incidence and/or assessment of reflux episodes (GI motility disorders, connective tissue disease like scleroderma, Barrett's esophagus, hiatal hernia > 3-4 cm, previous esophageal bleeding, esophageal varices, active gastric or duodenal ulcer disease, active esophagitis
- •Delayed gastric emptying, or endoscopic indications for a delay in gastric emptying or gastric outlet obstruction.
- •Neurologic/psychiatric disorders including a family history of epilepsy clinically significant cardiac disease
- •Diabetes mellitus or other metabolic disorders including hyperlipidemia requiring treatment
- •Any significant acute or chronic conditions except for following treated by the quoted drugs with a stable therapy for at least 4 weeks:
- •Hypertension well-controlled with the following:
- •ACE inhibitors: benazepril, captopril, cilazapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril tert-butylamine, quinapril, ramipril, spirapril, trandolapril, zofenopril, and/or
- •angiotensin II receptor antagonists: candesartan cilexetil, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, and/or
- •diuretics: amiloride, bendroflumethiazide, bumetanide, canrenoate de potassium, chlortalidone, cicletanine, clopamide, cyclothiazide, furosemide, hydrochlorothiazide, indapamide, methyclothiazide, piretanide, spironolactone, torasemide, triamterene, xipamide, and/or
- •calcium antagonists: bepridil, felodipine, isradipine, lercanidipine, manidipine, nimodipine, nitrendipine, amlodipine, nicardipine BUT NOT diltiazem, nifedipine, verapamil
- •Well-compensated asthma with topical use of corticosteroids and/or β2-mimetics
- •Patients on thyroid hormone therapy with a normal TSH value.
- •Nonsteroidal anti-inflammatory drugs including aspirin use in the week prior to treatment/impedance monitoring.
- •Patients with body mass index ≥
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Gastroesophageal reflux episodes as assessed by impedance measurements in the 4-hour period following a standardized high-fat meal in patients with GERD.
次要结局
- Effects of AFQ056 on other impedance/pH parameters, including but not limited to the rate of reflux episodes at various time intervals
- Pharmacokinetics (PK) of two AFQ056 single oral doses in patients with GERD.
- Safety and tolerability of oral AFQ056 in GERD patients.
- Relationships between AFQ056 blood levels and/or how the body interacts with the medication and overall reflux incidence
- Validation of the reflux model used in this study using baclofen as positive control.
研究者
研究点 (5)
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