- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562884
Efficacy, Safety and Tolerability of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy (EASY)
May 29, 2019 updated by: Ipsen
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
297
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100730
- Peking Union Medical College Hospital
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Beijing, China, 100034
- Peking University First Hospital
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Beijing, China, 100050
- Beijing Frendship hospital,Capital Medical University
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Chengdu, China, 610041
- West China Hospital, Sichuan University
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Guangzhou, China, 510080
- The First Affiliated Hospital, Sun Yat-sen University
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Hangzhou, China, 310009
- The Second Affiliated Hospital Zhe Jiang University of School
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Nanjing, China, 210029
- Jiangsu Province Hospital
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Shanghai, China, 200032
- Zhong Shan Hospital
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Tianjin, China, 300052
- Tianjin Medical University General Hospital
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Wuhan, China, 430030
- Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.)
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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.)
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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).
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of cleanliness by investigators using the Boston Bowel Preparation Scale (BBPS)
Time Frame: Day 2
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Day 2
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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
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Through study completion, an average of 1 year
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Rate of polyp detection, evaluated by the investigator
Time Frame: Through study completion, an average of 1 year
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Through study completion, an average of 1 year
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Rate of adenomas detected, evaluated by the investigator
Time Frame: Through study completion, an average of 1 year
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Through study completion, an average of 1 year
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Rate of other lesions including cancer, evaluated by the investigator
Time Frame: Through study completion, an average of 1 year
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Through study completion, an average of 1 year
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Proportion of subjects for whom total colonoscopy could be completed, evaluated by the investigator
Time Frame: Through study completion, an average of 1 year
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Through study completion, an average of 1 year
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Investigator satisfaction evaluated by 5-point Likert scale score
Time Frame: Day 2
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Answers will be given on a 5-point rating scale.
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Day 2
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Duration of the colonoscopy
Time Frame: Day 2
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Time from colonoscopy insertion to the time to reach the caecum.
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Day 2
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Patient compliance with BLI800 versus Fortrans®
Time Frame: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Patient Satisfaction with BLI800 versus Fortrans®
Time Frame: Day 2
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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.
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Day 2
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Patient tolerability with BLI800 versus Fortrans®
Time Frame: Day 2
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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).
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Day 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
April 28, 2019
Study Completion (Actual)
April 28, 2019
Study Registration Dates
First Submitted
May 17, 2018
First Submitted That Met QC Criteria
June 8, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
May 30, 2019
Last Update Submitted That Met QC Criteria
May 29, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-CN-58800-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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