NCT06994585

Brief Summary

This study aims to compare the intestinal cleansing efficacy, safety, tolerability, and acceptability of sodium picosulfate/magnesium citrate and polyethylene glycol in Taiwan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
Last Updated

January 12, 2026

Status Verified

December 1, 2023

Enrollment Period

8 days

First QC Date

May 20, 2025

Last Update Submit

January 8, 2026

Conditions

Bowel Preparation

Keywords

Drinklear powder，Niflec Powder，Picosulfate Sodium/ Citric Acid / Magnesium Oxide， Polyethylene Glycol，Bowel Cleansing Efcacy，bowel preparation

Outcome Measures

Primary Outcomes (1)

  • Bowel cleansing effectiveness

    will be assessed using the Aronchick Scale

    1 day

Study Arms (2)

Drinklear

EXPERIMENTAL

sodium picosulfate/magnesium citrate

Drug: Drinklear

Niflec

EXPERIMENTAL

Polyethylene Glycol

Drug: Niflec

Interventions

DrinklearDRUG

Our hospital invites outpatient patients aged 20 to 75 years who are scheduled to undergo colonoscopy and are willing to participate in this research study. After obtaining informed consent and signing the consent form, participants will be randomly assigned to receive either Polyethylene Glycol (Niflec Powder, China Chemical \& Pharmaceutical Co., Ltd., Taiwan) or Picosulfate Sodium/Citric Acid/Magnesium Oxide (Drinklear Powder, China Chemical \& Pharmaceutical Co., Ltd., Taiwan) as the bowel preparation for colonoscopy.

Drinklear
NiflecDRUG

Our hospital invites outpatient patients aged 20 to 75 years who are scheduled to undergo colonoscopy and are willing to participate in this research study. After obtaining informed consent and signing the consent form, participants will be randomly assigned to receive either Polyethylene Glycol (Niflec Powder, China Chemical \& Pharmaceutical Co., Ltd., Taiwan) or Picosulfate Sodium/Citric Acid/Magnesium Oxide (Drinklear Powder, China Chemical \& Pharmaceutical Co., Ltd., Taiwan) as the bowel preparation for colonoscopy.

Niflec

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • outpatient patients at our institution, aged 20 to 75 years, who are scheduled to undergo colonoscopy and are willing to participate in this research study.

You may not qualify if:

  • patients with allergies to bowel preparation agents, those who fail to show up on the scheduled date, patients who refuse to participate, those unable to follow preparation instructions, individuals with intestinal perforation, gastric retention, gastrointestinal obstruction, or bowel obstruction, severe renal insufficiency (CrCl below 30 mL/min), pregnant individuals, toxic megacolon, and patients with colorectal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, Taiwan, 24352, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Inclusion criteria include outpatient patients at our institution, aged 20 to 75 years, who are scheduled to undergo colonoscopy and are willing to participate in this research study. Exclusion criteria comprise patients with allergies to bowel preparation agents, those who fail to show up on the scheduled date, patients who refuse to participate, those unable to follow preparation instructions, individuals with intestinal perforation, gastric retention, gastrointestinal obstruction, or bowel obstruction, severe renal insufficiency (CrCl below 30 mL/min), pregnant individuals, toxic megacolon, and patients with colorectal cancer. Statistical Analysis Plan for this study: This is a non-inferiority study with a one-sided non-inferiority hypothesis. The non-inferiority margin is set at 0.1. The sample size for each group is 220, resulting in a total of 440 participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

March 20, 2024

Primary Completion

March 28, 2024

Study Completion

January 21, 2025

Last Updated

January 12, 2026

Record last verified: 2023-12

Locations

TW(1)