Efficacy, Safety and Tolerability of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy

PHASE3CompletedINTERVENTIONAL
Enrollment

297

Participants

Timeline

Start Date

July 1, 2018

Primary Completion Date

April 28, 2019

Study Completion Date

April 28, 2019

Conditions
Diagnosis Disease
Interventions
DRUG

BLI800

Two bottles of BLI800 are needed for appropriate cleansing of the bowel. Prior to administration, the content of each bottle must be diluted in water, using the cup provided, to a total volume of approximately 0.5 L, and must be followed by the ingestion of 1 additional litre of water.

DRUG

Fortrans®

Fortrans® (Powder for Oral Solution) will be given according to Chinese approved Summary of Product Characteristics (SmPC). Fortrans® is provided as a powder for Polyethylene Glycol (PEG) based solution available in sachets containing a white powder readily miscible with water. The dosing for Fortrans® administration will be adapted to subjects' body weight as following: 1 L of solution for 15 to 20 kg, an average of 3 to 4 L (maximum 4 L).

Trial Locations (10)

100034

Peking University First Hospital, Beijing

100050

Beijing Frendship hospital,Capital Medical University, Beijing

100730

Peking Union Medical College Hospital, Beijing

200032

Zhong Shan Hospital, Shanghai

210029

Jiangsu Province Hospital, Nanjing

300052

Tianjin Medical University General Hospital, Tianjin

310009

The Second Affiliated Hospital Zhe Jiang University of School, Hangzhou

430030

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

510080

The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY