Efficacy, Safety and Tolerability of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy (EASY)
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|ClinicalTrials.gov Identifier: NCT03562884|
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diagnosis Disease||Drug: BLI800 Drug: Fortrans®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||297 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy, Safety and Tolerability of a Split-dose of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy: A Phase III, Multicentre, RANDOMIZED, 2 Parallel- Group, Comparative Versus Fortrans®, Non-inferiority, Investigator/Assessor-blinded Study|
|Actual Study Start Date :||July 1, 2018|
|Actual Primary Completion Date :||April 28, 2019|
|Actual Study Completion Date :||April 28, 2019|
BLI800 given orally as a split-dose: 1st dose the evening before colonoscopy (e.g. at 6:00 p.m.- 8:00 p.m.) and 2nd dose on the morning of colonoscopy, 10 to 12 hours after the evening dose (e.g. at 5:00 a.m.-7:00 a.m.)
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.
Active Comparator: Fortrans®
Fortrans® given orally as a split dose: 1st dose the evening before colonoscopy (e.g. at 6:00 p.m - 8:00 p.m.) and 2nd dose on the morning of colonoscopy, 10 to 12 hours after the evening dose (e.g. at 5:00 a.m.-7:00 a.m.)
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).
- The proportion of subjects with successful overall preparation based on a centrally assessed global BBPS score (for all segments) ≥ 6 (centralised assessment). [ Time Frame: Through study completion, an average of 1 year ]Efficacy of BLI800 versus Fortrans® will be evaluated with the BBPS global score which ranges from 0 to 9. It will be blindly scored and evaluated by a centralised assessment (blinded assessors will assess the electronic record of colonoscopy and rate it).
- Assessment of cleanliness by investigators using the Boston Bowel Preparation Scale (BBPS) [ Time Frame: Day 2 ]
- BBPS score by segment (0 to 3), scored in blind and evaluated by centralised assessment [ Time Frame: Through study completion, an average of 1 year ]
- Rate of polyp detection, evaluated by the investigator [ Time Frame: Through study completion, an average of 1 year ]
- Rate of adenomas detected, evaluated by the investigator [ Time Frame: Through study completion, an average of 1 year ]
- Rate of other lesions including cancer, evaluated by the investigator [ Time Frame: Through study completion, an average of 1 year ]
- Proportion of subjects for whom total colonoscopy could be completed, evaluated by the investigator [ Time Frame: Through study completion, an average of 1 year ]
- Investigator satisfaction evaluated by 5-point Likert scale score [ Time Frame: Day 2 ]Answers will be given on a 5-point rating scale.
- Duration of the colonoscopy [ Time Frame: Day 2 ]Time from colonoscopy insertion to the time to reach the caecum.
- Patient compliance with BLI800 versus Fortrans® [ Time Frame: Through study completion, an average of 1 year ]The proportion of subjects who fully followed prescription will be analyzed. The compliance with the instructions of use provided in the prescription will be evaluated by the measurement of unused preparation and fluid intake recorded by the subject on the subject's leaflet. A subject will be considered as fully compliant with the instructions of use provided in the prescription if he drinks the whole preparation and any required further fluid intake.
- Patient Satisfaction with BLI800 versus Fortrans® [ Time Frame: Day 2 ]Patient satisfaction will be evaluated by patient satisfaction scale. Satisfaction of bowel preparation will be performed by questionnaire assessing difficulty using bowel-cleansing preparations, ability to consume preparation, acceptability of taste, overall experience and questions regarding acceptance or refusal of future use of the same bowel preparation.
- Patient tolerability with BLI800 versus Fortrans® [ Time Frame: Day 2 ]Evaluation of patient tolerability will be performed by patient tolerability questionnaire. Tolerability will be assessed by questionnaire recording the presence and intensity of specific symptoms (nausea, vomiting, abdominal pain, abdominal distension, and abdominal discomfort).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562884
|Peking University First Hospital|
|Beijing, China, 100034|
|Beijing Frendship hospital,Capital Medical University|
|Beijing, China, 100050|
|Peking Union Medical College Hospital|
|Beijing, China, 100730|
|West China Hospital, Sichuan University|
|Chengdu, China, 610041|
|The First Affiliated Hospital, Sun Yat-Sen University|
|Guangzhou, China, 510080|
|The Second Affiliated Hospital Zhe Jiang University of School|
|Hangzhou, China, 310009|
|Jiangsu Province Hospital|
|Nanjing, China, 210029|
|Zhong Shan Hospital|
|Shanghai, China, 200032|
|Tianjin Medical University General Hospital|
|Tianjin, China, 300052|
|Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology|
|Wuhan, China, 430030|
|Study Director:||Ipsen Medical Director||Ipsen|