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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562884
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diagnosis Disease Drug: BLI800 Drug: Fortrans® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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.)
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.

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.)
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).




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Assessment of cleanliness by investigators using the Boston Bowel Preparation Scale (BBPS) [ Time Frame: Day 2 ]
  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 ]
  3. Rate of polyp detection, evaluated by the investigator [ Time Frame: Through study completion, an average of 1 year ]
  4. Rate of adenomas detected, evaluated by the investigator [ Time Frame: Through study completion, an average of 1 year ]
  5. Rate of other lesions including cancer, evaluated by the investigator [ Time Frame: Through study completion, an average of 1 year ]
  6. Proportion of subjects for whom total colonoscopy could be completed, evaluated by the investigator [ Time Frame: Through study completion, an average of 1 year ]
  7. Investigator satisfaction evaluated by 5-point Likert scale score [ Time Frame: Day 2 ]
    Answers will be given on a 5-point rating scale.

  8. Duration of the colonoscopy [ Time Frame: Day 2 ]
    Time from colonoscopy insertion to the time to reach the caecum.

  9. 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.

  10. 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.

  11. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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China
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
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03562884    
Other Study ID Numbers: A-CN-58800-004
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No