Clinical trial NCT03562884: Efficacy, Safety and Tolerability of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diagnosis Disease
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The proportion of subjects with successful overall preparation based on a centrally assessed global BBPS score (for all segments) ≥ 6 (centralised assessment).
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Assessment of cleanliness by investigators using the Boston Bowel Preparation Scale (BBPS)
timeFrame: Day 2
measure: BBPS score by segment (0 to 3), scored in blind and evaluated by centralised assessment
timeFrame: Through study completion, an average of 1 year
measure: Rate of polyp detection, evaluated by the investigator
timeFrame: Through study completion, an average of 1 year
measure: Rate of adenomas detected, evaluated by the investigator
timeFrame: Through study completion, an average of 1 year
measure: Rate of other lesions including cancer, evaluated by the investigator
timeFrame: Through study completion, an average of 1 year
measure: Proportion of subjects for whom total colonoscopy could be completed, evaluated by the investigator
timeFrame: Through study completion, an average of 1 year
measure: Investigator satisfaction evaluated by 5-point Likert scale score
timeFrame: Day 2
measure: Duration of the colonoscopy
timeFrame: Day 2
measure: Patient compliance with BLI800 versus Fortrans®
timeFrame: Through study completion, an average of 1 year
measure: Patient Satisfaction with BLI800 versus Fortrans®
timeFrame: Day 2
measure: Patient tolerability with BLI800 versus Fortrans®
timeFrame: Day 2
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Frendship hospital,Capital Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhe Jiang University of School
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: Zhong Shan Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: