Efficacy and Safety study of KKM-151 for Bowel Cleansing prior to Colonoscopy: Randomized, Active-controlled, Single blind(assessor-blinded), Multi-center Phase III Clinical Trial.

Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 250 人开始时间: 待定最近更新: 2020年6月15日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 250

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 19(Year) 至 79(Year)（—）
性别: All

入选标准

•Inclusion Criteria
•1. Men or women between 19 and 79 years of age.
•2. Subject who are scheduled for an elective colonoscopy.
•3. Ability to complete the entire procedure and to comply with study instructions.
•4. Will provide completed and signed written informed consents

排除标准

•Exclusion Criteria
•1. Subjects with hypersensitivity to any ingredients in the study medications.
•2. Subjects with known or suspected ileus, gastrointestinal obstruction, gastrointestinal ulcer, intestinal perforation, gastroparesis, gastric outlet obstruction, toxic colitis, mega colon, severe ulcerative colitis and inflammatory bowel disease.
•3. Subjects with gastrointestinal surgery such as colectomy or gastrectomy(except simple polyp resection), or with acute surgical abdominal conditions(e.g. acute appendicitis).
•4. Subjects with clinically significant abnormal laboratory values of electrolytes at screening,
•- Na : <130 mmol/L or >150 mmol/L
•- K: <3.0 mmol/L or >5.5 mmol/L
•- Corrected serum Ca: <8.0mg/dL(2.0mmol/L) or >11.5mg/dL(2.9mmol/L)
•5. Subjects with severe renal disease (serum creatinine > 2.0mg/dL at screening)
•6. Subjects having severe congestive heart failure(NYHA III, IV) within previous 3 months at signing consents.
•7. Subjects with ascites of any etiology.
•8. Subjects with severe abdominal distension or abdominal pain
•9. Subjects with history of phenylketonuria, glucose-6-dehydrogenase deficiency
•10. Rhabdomyolysis patients
•11. Subjects prone to lung aspiration and who fall under one of the following:
•-Those with conscious disabilities, those with vomiting reflex disorders, those with nasogastric tube feeding, patients with dysphagia
•12. Subjects with active malignancy
•13. Subjects taking any other investigational medications within 3 months prior to screening.
•14. Subjects who should continuously take medications which could derange water or electrolyte balance during interventional period (diuretics, Angiotensin converting enzyme(ACE) inhibitor, Systemic corticosteroids, Digoxin, Lithium)
•15. Subjects with childbearing potential without an effective method of birth control (e.g. oral contraceptive, intrauterine device, surgical sterilization, hysterectomy) or pregnant or lactating women.
•16. Subjects who is classified not suitable for this study by investigators

研究者

发起方

Yonsei University Health System, Gangnam Severance Hospital

相似试验

已完成

3 期

Safety and Efficacy of PBK-1701TC for Bowel Cleansing Before ColonoscopyColonic DiseasesIntestinal DiseaseGastrointestinal DiseaseDigestive System Disease

NCT03509220Pharmbio Korea Co., Ltd.235

尚未招募

1 期

Clinical study on treatment of female rheumatoid arthritis by Kunbixiao decoctio

ITMCTR2100004992Xiyuan Hospital, China Academy of Chinese Medical Sciences

已完成

2 期

Study to check the improvement in hair health.

CTRI/2022/11/047219Transformative Learning Solutions Pvt Ltd30

尚未招募

2 期

Effect of Kapikacchu basti in management of Kampavata (Parkinsons disease)

CTRI/2017/08/009345Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

已完成

2 期

Study Evaluating EKB-569 in Advanced Colorectal CancerColorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

NCT00072748Wyeth is now a wholly owned subsidiary of Pfizer63