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OpenTrials
Completed

NCT Number: NCT03562884

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

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.

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Key information

Conditions

Diagnosis Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Frendship hospital,Capital Medical University, Beijing, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

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).

    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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: EASY

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2018
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.