Efficacy, Safety and Tolerability of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy
- Registration Number
- NCT03562884
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose is to demonstrate that BLI800 is non-inferior, on overall colon cleansing, to Fortrans® (a reference colonic lavage in China) administered in adult subjects scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 297
- Provision of written informed consent signed prior to any study related procedures.
- Male or female, at least 18 years old undergoing colonoscopy for a routine diagnostic indication, such as: a. Routine cancer screening b. Polyp or neoplasm history c. Diagnostic procedure for occult bleeding or anaemia d. Diarrhoea or constipation of unknown aetiology e. Inflammatory Bowel Disease (IBD) not in severe active phase
- In good clinical condition (physical exam and medical history)
- Adequate fluid balance, and adequate electrolyte balance (measured during screening K, Na, Cl, anion gap/bicarbonate/carbon dioxide content within normal/within ±10% of normal range)
- Abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
- Advanced carcinoma or any other colon disease leading to excessive mucosal fragility.
- Known or suspected gastrointestinal (GI) obstruction, gastric retention, gastroparesis, or disorder of gastric emptying.
- Known or suspected ileus.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fortrans® 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.) BLI800 BLI800 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.)
- Primary Outcome Measures
Name Time Method The proportion of subjects with successful overall preparation based on a centrally assessed global BBPS score (for all segments) ≥ 6 (centralised assessment). 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).
- Secondary Outcome Measures
Name Time Method Rate of adenomas detected, evaluated by the investigator Through study completion, an average of 1 year Proportion of subjects for whom total colonoscopy could be completed, evaluated by the investigator Through study completion, an average of 1 year Investigator satisfaction evaluated by 5-point Likert scale score Day 2 Answers will be given on a 5-point rating scale.
BBPS score by segment (0 to 3), scored in blind and evaluated by centralised assessment Through study completion, an average of 1 year Rate of other lesions including cancer, evaluated by the investigator Through study completion, an average of 1 year Duration of the colonoscopy Day 2 Time from colonoscopy insertion to the time to reach the caecum.
Patient compliance with BLI800 versus Fortrans® 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.
Assessment of cleanliness by investigators using the Boston Bowel Preparation Scale (BBPS) Day 2 Rate of polyp detection, evaluated by the investigator Through study completion, an average of 1 year Patient Satisfaction with BLI800 versus Fortrans® 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® 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).
Trial Locations
- Locations (10)
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, China
Zhong Shan Hospital
🇨🇳Shanghai, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
The First Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Beijing Frendship hospital,Capital Medical University
🇨🇳Beijing, China
The Second Affiliated Hospital Zhe Jiang University of School
🇨🇳Hangzhou, China
Jiangsu Province Hospital
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Beijing, China