A Phase 3 Clinical Trial to Efficacy and Safety study of KKM-151 for Bowel Cleansing prior to Colonoscopy

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of colon cleanliness evaluated by an independent evaluator using the Harefield Cleansing Scale

Secondary Outcome Measures

Name	Time	Method
Colon cleansing success rate evaluated by colonoscopists using Harefield Cleansing Scale;Overall satisfaction evaluated by colonoscopist;Subject questionnaire evaluation about the total volume of drugs;Subject questionnaire evaluation about the taste of drugs;Subject questionnaire evaluation about the difficulty of ingestion of drugs;Whether or not to re-use, subject questionnaire evaluation;Evaluate the number of bowel movements during the period of intake using subject’s diary;Overall satisfaction with taking method, subject questionnaire evaluation;Intracolonic flammable gas concentration