NCT00277550撤回4 期
A Randomized, Double-blind, Placebo-controlled Evaluation of the Effects of Tegaserod (6 mg b.i.d) on Whole Gut Transit Time in Patients With Chronic Idiopathic Constipation and Dyspepsia
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Novartis
- 主要终点
- To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
研究概览
简要总结
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 18 to 64 years of age
- •Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:
- •Less than 3 bowel movements per week
- •Hard or lumpy stools
- •Straining during bowel movements
- •Feeling of incomplete evacuation
- •Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating
排除标准
- •Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives
- •Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians
- •Patients with constipation secondary to medication use as determined by the study physician
- •Patients with clinically significant abnormal TSH levels at screening
- •Patients that have heartburn or abdominal pain as their predominant GI symptom
- •Evidence of cathartic colon or a history of laxative abuse
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
次要结局
- To evaluate the PD effects of tegaserod on upper & lower GI transit
- To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments
研究者
相似试验
已完成
1 期
A Study to Investigate the Effect of JNJ-67953964 on Gastric Mucosal Integrity in Healthy Male and Female ParticipantsHealthyNCT04185051Janssen Research & Development, LLC76
已完成
1 期
To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy SubjectsGastric UlcerNCT03291418Antibe Therapeutics Inc.258
已完成
2 期
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic ConstipationConstipationNCT00306748Ironwood Pharmaceuticals, Inc.40
撤回
1 期
A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese SubjectsObesityNCT01472848Pfizer
已完成
3 期
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 DiabetesDiabetes Mellitus Type 2NCT00809705Hoffmann-La Roche60