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

NCT03562884 | Completed Phase 3

• 1 other identifier: A-CN-58800-004
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 10

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.

Conditions

Diagnosis Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  Through study completion, an average of 1 year

Secondary Outcomes (11)

• Assessment of cleanliness by investigators using the Boston Bowel Preparation Scale (BBPS)

  Day 2

• 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 polyp detection, evaluated by the investigator

  Through study completion, an average of 1 year

• Rate of adenomas detected, evaluated by the investigator

  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

Study Arms (2)

BLI800

EXPERIMENTAL

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®

ACTIVE COMPARATOR

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®

Interventions

BLI800 DRUG

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.

BLI800

Fortrans® DRUG

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).

Fortrans®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (10)

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Frendship hospital,Capital Medical University

Beijing, 100050, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, 510080, China

Location

The Second Affiliated Hospital Zhe Jiang University of School

Hangzhou, 310009, China

Location

Jiangsu Province Hospital

Nanjing, 210029, China

Location

Zhong Shan Hospital

Shanghai, 200032, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430030, China

Location

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 20, 2018
• Study Start: July 1, 2018
• Primary Completion: April 28, 2019
• Study Completion: April 28, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

CN (10)