Colon cleansing efficacy and safety with 1 L Plenvu® versus 2 L CLICOOL® study

Colon cleansing efficacy and safety with 1 L Plenvu® versus 2 L CLICOOL®: Phase IV, multicenter, randomized, evaluator-blinded study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005894

Enrollment

360

Registered

2021-02-16

Start date

2020-02-12

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1 L PEG-Asc Plenvu group - Using Plenvu, total 1L, in split dose, Oral administration - 500ml of Plenvu with 500ml of water from 6pm the day before colonoscopy, another 500mL Plevu with 500ml o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients 18 to 80 years of age who had scheduled for colonoscopy and signed the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. diagnosed with colorectal cancer and inflammatory bowel disease (IBD) 2. has undergone a bowel resection 3. Pregnant or nursing woman 4. with severe renal failure (creatinine cleavage <30mL/min) 5. have undergone colon endoscopy within 6 months of consent date 6. participated in other clinical trials within 6 months of the consent date 7. Should not be included in this study for any reason of the PI’s judgement.

Design outcomes

Primary

Measure	Time frame
Comparison of the success rate of the total colon cleansing effect by BBPS	—

Secondary

Measure	Time frame
Comparison of PDR by section (Right, Proximal, Left Colon);Comparison of ADR by section (Right, Proximal, Left Colon);Comparison of BBPS Cleanness Scores by Section (Right, Proximal, Left Colon);Comparison of the MPP (mean poly per patient);Comparison of the MAP(mean adenoma per patient );Interval Time between completion of secondary medication and start of colonoscopy;Comparison of patient's questionnaire items such as side effects after taking the drug, patient evaluation	—

Measure

Time frame

Comparison of PDR by section (Right, Proximal, Left Colon);Comparison of ADR by section (Right, Proximal, Left Colon);Comparison of BBPS Cleanness Scores by Section (Right, Proximal, Left Colon);Comparison of the MPP (mean poly per patient);Comparison of the MAP(mean adenoma per patient );Interval Time between completion of secondary medication and start of colonoscopy;Comparison of patient's questionnaire items such as side effects after taking the drug, patient evaluation

—

Countries

Korea, Republic of

Contacts

Public ContactYoon Tae Jeen

Korea University Anam Hospital

Outcome results