Prospective, Interventional, Single Arm Study in Outpatients Undergoing Sigmoidoscopy for Evaluation of Efficacy and Safety of Kleen Enema 120ml (Phosphate Enema)
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Excellent Preparation for Sigmoidoscopy (efficacy)
研究概览
简要总结
The Purpose of the study is to determine the efficacy of Kleen Enema® (Phosphate Enema) for bowel preparation in out-patients under going sigmoidoscopy procedure and to evaluate the safety behavior of Kleen Enema® in outpatients requiring sigmoidoscopy
详细描述
Safety and therapeutic efficacy of Phosphate enema (Kleen Enema®) in patients undergoing sigmoidoscopy. Prospective, interventional, single arm study in patients undergoing day care sigmoidoscopy for evaluation of efficacy and safety of Kleen Enema®(120ml phosphate enema); manufactured by Nabiqasim Industries (Pvt) Ltd, Karachi, Pakistan.
Methods &Material:
Study will be conducted in patients undergoing sigmoidoscopy in day care at Dow University of Health Sciences, Ojha campus, Karachi. Each subject will receive the single dose of investigational drug (phosphate enema 120ml). Objectives of the study
- To determine the efficacy of Kleen Enema® for bowel preparation in out-patients undergoing to sigmoidoscopy procedure.
- To evaluate the Safety of Kleen Enema® in outpatients requiring sigmoidoscopy.
Rationale of the Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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/Female; aged 18-60 years.
- •Out-patients admitted for day care sigmoidoscopy requiring left sided bowel preparation
- •Able to understand the informed consent, answer the questions either independently or with someone helps
排除标准
- •In-patients undergoing sigmoidoscopy or as emergency procedures.
- •Immunosuppressed patients.
- •Patients with electrolyte imbalance or disturbance, Hyperphosphatemia, Hypocalcemia, Hypokalemia, Hypernatremia, Metabolic acidosis.
- •Patients having nausea, vomiting, diarrhea at the time of investigational drug administration.
- •Patients administering the medications known to affect renal perfusion, function, or hydration(Renal failure or acute kidney injury)
- •Patients taking diuretics or other medications within two days prior to the procedure which may alter electrolytes
- •Patients with known hypersensitivity to any ingredient of the study drug/phosphate.
- •Patients requiring colostomy.
- •Conditions causing decreased gastric motility, e.g.,Suspected intestinal obstruction,Paralytic ileus Anorectal stenosis, Imperforate anus, Congenital or acquired megacolon
- •Undiagnosed gastrointestinal pathology, e.g. Symptoms of appendicitis, intestinal perforation or active inflammatory bowel disease, Undiagnosed rectal bleeding, Dehydration and generally in all cases where absorption capacity is increased or elimination capacity is decreased
- •Patients with any neuropathy, renal impairment, liver diseases, diabetes mellitus, Hypertension and any Cardiovascular disease,History of asthma, glaucoma, or raised intraocular pressure.
研究组 & 干预措施
Phosphate Enema
Phosphate Enema consisting on Monobasic Sodium Phosphate (USP) 19.2 gm /120 ml and Dibasic Sodium Phosphate (USP) 7.2 gm/120 ml Dosage Form: Enema Frequency: One time; 30 minutes before Sigmoidoscopy
干预措施: Phosphate Enema (Kleen® Enema) (Drug)
结局指标
主要结局
Excellent Preparation for Sigmoidoscopy (efficacy)
时间窗: 30 minutes after administration of the Enema
i. Small amounts of faecal material in scattered locations removable by suctioning and not preventing satisfactory visualisation of bowel mucosa; ii. Excellent preparation, no faecal material.
次要结局
未报告次要终点