NCT01711918已完成不适用
Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
Ron Schey1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Improvement of Overall Symptoms Based on Likert Scale
研究概览
简要总结
To provide oral domperidone to patients between the ages of 18 and 60 years of age, according to the investigator's judgment, a prokinetic effect is needed for the relief of severe gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal pain. We will recruit patients for two years and the patients will be given domperidone for up to two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 or Female
- •Age 18 - 60
- •Symptoms or manifestation secondary to gastroparesis such as vomiting, nausea, the feeling you are full after you start eating, and abdominal pain.
- •Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms which includes gastric emptying scintigraphy, esophagogastroduodenoscopy (EGD), and the patient's subjective symptoms.
- •Subject has signed informed consent for the administration of domperidone that informs the patient of potential adverse events
- •Female subjects must be:
- •surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal ligation)
- •if sexual active, practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy. A double barrier method such as condoms, diaphragms, or cervical caps with spermicidal foam, cream, or gel may be used as a method of birth control
排除标准
- •History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, atrial fibrilation and Torsade des Pointes, subjects with minor forms of ectopy (PACs) are not necessarily excluded
- •Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTC>450 milliseconds for males, QTc>470 milliseconds for females)
- •Clinically significant electrolyte disorders
- •Gastrointestinal hemmorrhage or obstruction
- •Presence of a prolactinoma (prolactin-releasing pituitary tumor)
- •Pregnant or breast feeding female
- •Known allergy to domperidone The following medications are prohibited during the study: antidepressants: doxepin, clomipramine, amopxapine, trazodone, venlafaxine, nefazodone, fluvoxamine, paroxetine, fluoxetine, sertraline, amitriptyline, maprotiline, desipramine, nortriptyline, trimipramine, imipramine, protriptyline; anti-psychotics: haloperidol, chlorpromazine, chlorpromazine pimozide, sertindole, quetiapine, mesoridazine, perphenazine, lfluphenazine, promazine, trifluoperazine; anti-emetics: prochlorperazine, thioridazine, promethazine, mesoridazine, theiethylperazine, perphazine, dolasetron, dronabinol, droperidol; anti-infective agents: erythromycin, clarithromycin, troleandomycin, norfloxcin, quinine sulfate, quinupristin and dalfopristin, pentamidine, sparfloxacin, grepafloxacin, azithromycin, ofloxacin, levofloxacin; anti-fungal agents: fluconazole, itraconazole, ketoconazole, miconazole, terconazole, ticonazole, butaconazole; antivirals: foscarnet; protease inhibitors: indinavir, amprenavir, ritonavir, nelfinavir, squinavir; antihypertensives: nicardipine, isradipine, moexipril/HCTZ; calcium channel blockers: verapamil, diltiazem, deltiazem/enalapril, verapamil/trandolapril, tocainide, bepridil; anti-arrhythmics: disopyramide, quinidine, procainamide, flecainide, sotalol, bretylium, amiodarone, ibutilide, moricizine; diueretics: bumetanide, furosemide, torsemide, etharcrynic acid, chlorothiazide, indapamide; antilipemics: probucol, bepridil, mibefradil; hematological agents: cilostazol; respiratory agents: zafirlukast, salmetrol; gastrointestinal agents: cimetidine, cisapride; antidiarrheal: octreotide; antihistamines: azelastine, clemastine; migraine treatment: naratriptan, sumatriptan, zolmitriptan; antimalarial: halofantrine; muscle relaxants: tizanidine; narcotic dependence: levomethadyl; miscellaneous: tamoxifen, warfarin, phenytoin, ziprasidone, risperidone, formoterol fumarate, sildenafil; drugs that prolong the QT Interval: albuterol, alfuzosin, amantadine, amisulpride, amphetamine, arsenic trioxide, astemizole, atazanavir, atomoxetine, chloral hydrate, chloroquine, ciprofloxacin, citalopram, clozapine, cocaine, dexmethylphenidate, diphenhydramine, dobutamine, dofetilide, dopamine, dronedarone, ephedrine, epinephrine, eribulin, escitalopram, famotidine, felbamate, fenfluramine, fingolimod, fosphenytoin, galantamine, gatifloxacin, gemifloxacin, granisetron, iloperidone, isoproterenol, lapatinib, levalbuterol, lisdexamfetamine, lithium, metaproterenol, methadone, methylphenidate, midodrine, moxifloxacin, nilotinib, norepinephrine, ondansetron, oxytocin, paliperidone, perflutren lipid microspheres, phentermine, phenylephrine, phenylpropanolamine, protriptyline, pseudoephedrine, ranolazine, ritodrine, toxithromycin, sibutramine, solifenacin, sunitinib, tacrolimus, telithromycin, terbutaline, terfenadine, tolterodine, trimethoprim-sulfa, vandetanib, vardenafil, voriconazole.
研究组 & 干预措施
Domperidone
Experimental
Participants will received domperidone at a dose of 10mg given up to three times per day
干预措施: Domperidone (Drug)
结局指标
主要结局
Improvement of Overall Symptoms Based on Likert Scale
时间窗: Baseline and End of study (2 years or last visit if patient withdraws)
A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
次要结局
- Improvement of Nausea Based on Likert Scale(Baseline and End of study (2 years or last visit if patient withdraws))
- Improvement of Vomiting Based on Likert Scale(Baseline and End of study (2 years or last visit if patient withdraws))
- Improvement of Abdominal Bloating or Distention Based on Likert Scale(Baseline and End of study (2 years or last visit if patient withdraws))
- Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale(Baseline and End of study (2 years or last visit if patient withdraws))
研究者
Ron Schey
Clinical Assistant Professor
University of Iowa
研究点 (1)
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