NCT04483037

Different Dosing Time of Bowklean for the Bowel Preparation

Comparison of Same-Day and Split-Dose Preparation With Sodium Picosulfate/Magnesium Citrate (Bowklean) for Afternoon Colonoscopy: A Randomized Non-Inferiority Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: Changhua Christian Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon.

Detailed description

Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with similar efficacy and better tolerability than polyethylene glycol. However, there was limited data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose preparation for afternoon colonoscopy. This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy. One additional prospective observation group of 100 subjects receiving colonoscopy in the morning was included as an observation group to compare bowel preparation in morning and afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale, Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble Scale (TBS).

Conditions

• Bowel Preparation

Interventions

Type	Name	Description
DRUG	Bowklean	assigned intervention

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-07-23
• Last updated: 2021-07-23

Locations

1 site across 1 country: Taiwan