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OpenTrials
Completed

NCT Number: NCT04214301

An Open-Label Preference Evaluation of BLI800

The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Braintree Research Site 1, Great Neck, New York, United States

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About this study

The objective of this study is to evaluate the patient satisfaction and preference of BLI800 in adult patients undergoing colonoscopy.

Who can participate

Healthy volunteers accepted: No

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

Primary Inclusion Criteria:

  • Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication
  • 18 to 85 years of age (inclusive)
  • If female, and of child-bearing potential, is using an acceptable form of birth control
  • Negative urine pregnancy test at screening, if applicable
  • In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Primary Exclusion Criteria:

  • Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon
  • Subjects with ongoing severe, acute inflammatory bowel disease
  • Subjects who had previous significant gastrointestinal surgeries
  • Subjects with known severe renal, hepatic or cardiac insufficiency
  • Subjects undergoing insulin therapy for any indication
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration
  • Subjects undergoing colonoscopy for foreign body removal and/or decompression

Treatment and study plan

BLI800

Drug

BLI800 Bowel Preparation

Primary outcomes

  1. Ease of Preparation Consumption

    Time frame: 2 days

    Question: How easy or difficult was it to consume the study preparation?

Secondary outcomes

  1. Preparation Compliance

    Time frame: 2 days

    Question: Were you able to consume the entire preparation as instructed?

  2. Rating of Overall Experience

    Time frame: 2 days

  3. Comparison to Prior Preparation

    Time frame: 2 days

    How did this preparation experience compare to your prior experience?

  4. Willingness to Repeat Preparation

    Time frame: 2 days

    Would you ask your doctor for this preparation again if you need another colonoscopy in the future?

  5. Refuse if Prescribed Again

    Time frame: 2 days

    Would you refuse the same preparation again if it were to be prescribed to you in the future?

  6. Rating of Aftertaste

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Oct 23, 2023

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.

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