A Prospective, Single Center, Randomized, Single Blinded Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Gastric Transit Time
研究概览
简要总结
Summary:
This study investigates the use of oral dissolving metoclopramide during standard video capsule endoscopy. Metoclopramide is a pro -motility agent, that is, this medication helps with movement through the stomach and small bowel. This study will help us determine the effectiveness of oral dissolving metoclopramide on transit time through the stomach and small bowel of the video capsule that is ingested. This study may help with better diagnoses of pathology in the small bowel. Each patient enrolled in the study will either be assigned to a group that only ingests the capsule or the group that receives the oral dissolving metoclopramide plus capsule. Each patient will undergo the same standard procedures and precaution used during standard video capsule endoscopy. The patients that will qualify for the study are patients that are in need of video capsule endoscopy for further imaging of the small bowel. The patients must meet the inclusion criteria provided in the protocol and must not meet any of the exclusion criteria in the protocol. The hypothesis is that the patients that ingest the metoclopramide will have better capsule images and transit time and will allow for enhanced diagnosis of small bowel pathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years - 70 years old, male or female, belonging to any race or ethnic origin.
- •Patients necessitating video capsule endoscopy.
- •Patients who are willing and competent to sign an informed consent and to comply with study related visits and procedures.
排除标准
- •Patients below the age of 18 or greater than 70 years old.
- •Pregnant patients
- •Patients with a documented history of Parkinson's Disease or Parkinsonian Symptoms, Tardive Dyskinesia, history of neuroleptic malignant syndrome, history or seizure disorder.
- •Patients who are currently taking antipsychotic medications including typical and atypical antipsychotics.
- •Patients taking other drugs that may cause extrapyramidal reactions.
- •Patients with a history of cirrhosis or congestive heart failure.
- •Patients with a history of depression.
- •Patients with uncontrolled hypertension.
- •Patients with renal impairment, creatinine clearance < 40ml/minute.
- •Patients who have massive gastrointestinal hemorrhage, mechanical obstruction, or perforation.
- •Patients with a known history of pheochromocytoma, as this may precipitate hypertensive crisis.
- •Patients with a known sensitivity or intolerance to metoclopramide.
- •Patients who, in the investigator's opinion, are medically unstable, are unable to give informed consent, or whose risks outweigh the benefits of participating in the study.
- •Vulnerable subjects: Prisoners, persons with decisional incapacity, and any person who are directly involved in the study, including their immediate family members, and anybody who may have any conflict of interest.
研究组 & 干预措施
Oral Dissolving metoclopramide
Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy.
干预措施: metoclopramide (Drug)
结局指标
主要结局
Gastric Transit Time
时间窗: Day 1
Time for transit through small intestine.
次要结局
未报告次要终点