An Open-Label Preference Evaluation of BLI800

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2019-11-21

Brief Summary

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

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Detailed Description

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

Conditions

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Colonoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BLI800

Group Type EXPERIMENTAL

BLI800

Intervention Type DRUG

BLI800 Bowel Preparation

Interventions

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BLI800

BLI800 Bowel Preparation

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No