NCT01326117撤回4 期
Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis
Mark Feinglos1 个研究点 分布在 1 个国家开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- improvement in Gastric Emptying Study residual tracer amount
研究概览
简要总结
The investigators hypothesize that in adult patients with diabetic gastroparesis with Type 1 diabetes (HbA1c ≤ 10.5%), daily tadalafil use will significantly improve gastric emptying compared to baseline as measured by gastric emptying time.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes diagnosis
- •Age 18 - 65 years (inclusive)
- •Hemoglobin A1c ≤ 10.5% within the last 4 months
- •Diagnosis of gastroparesis, or symptoms consistent with gastroparesis (early satiety, chronic intermittent nausea or vomiting with food intake)
- •Patient has gastroparesis confirmed on screening study
- •A female patient is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea, or child-bearing potential with negative serum hCG prior to each gastric emptying study.
排除标准
- •Active nitrate use (e.g. Cialis, Viagra, Levitra, nitroglycerin, Isordil, Imdur, amyl nitrate/poppers)
- •Fasting fingerstick glucose > 250 mg/dL
- •History of abdominal surgery including gastric banding procedure
- •Patient is on chronic parenteral feeding
- •Patient has a history of eating disorders (anorexia nervosa, binge eating, bulimia)
- •Regular opiate use
- •Recent (last 6 weeks) history of poor control of diabetes e.g. hypoglycemia requiring medical intervention, diabetic ketoacidosis, admission for control diabetes or complications of diabetes
- •Acute severe gastroenteritis
- •The patient has participated in another clinical trial in the last 30 days.
- •Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study [e.g., prokinetic drugs, macrolide antibiotics (erythromycin), GLP-1 mimetics/analog, amylin analog]
- •History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition that would in the opinion of the investigator make the subject unsuitable for inclusion in this clinical study.
- •Chronic angina or NYHA class III or IV CHF
- •Concurrent use of ketoconazole or itraconazole
- •History of severe vision loss, retinitis pigmentosa, or non-arteritic anterior ischemic optic neuropathy (NAION)
- •History of CVA
- •Pregnant females as determined by positive serum hCG test
- •Lactating females
- •Uncontrolled hypertension (SBP > 160 or DBP > 100)
- •Hypotension (SBP < 90 or DBP < 60)
- •Other major medical conditions: priapism, sickle cell anemia, multiple myeloma, leukemia, active cancer diagnosis, HIV/AIDS, alcoholism, or bleeding diathesis.
- •Intolerance to active or inactive ingredients of Cialis, or intolerance to other PDE-5 inhibitors.
研究组 & 干预措施
tadalafil
Experimental
干预措施: tadalafil (Drug)
结局指标
主要结局
improvement in Gastric Emptying Study residual tracer amount
时间窗: 7 days with intervention
change in gastric emptying compared to baseline as measured by gastric emptying time.
次要结局
未报告次要终点
研究者
Mark Feinglos
Division Chief, Department of Endocrinology, Diabetes, and Metabolism
Duke University
研究点 (1)
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