A Phase 3 interventional study of BLI800 and Fortrans® in Diagnosis Disease, sponsored by Ipsen. Completed at 10 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by Ipsen · Phase 3, Interventional, and Diagnostic
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.
Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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®
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.
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).
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).
Time frame: Through study completion, an average of 1 year
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
Answers will be given on a 5-point rating scale.
Time frame: Day 2
Duration of the colonoscopy
Time from colonoscopy insertion to the time to reach the caecum.
Time frame: Day 2
Patient compliance with BLI800 versus Fortrans®
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.
Time frame: Through study completion, an average of 1 year
Patient Satisfaction with BLI800 versus Fortrans®
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.
Time frame: Day 2
Patient tolerability with BLI800 versus Fortrans®
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).
Time frame: Day 2
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ipsen