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Phase 4 Completed N=338 Randomized Single-blind Treatment

BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Colonoscopy · Bowel Preparation · Endoscopy
Source: ClinicalTrials.gov NCT01786629 ↗
Enrolled (actual)
338
Serious AEs
0.6%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent") — 95; 86 percentage of subjects

Summary

To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as bowel preparations prior to colonoscopy in adult patients.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent")
95; 86

Eligibility Criteria

Inclusion Criteria

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.

At least 18 years of age

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 who had previous significant gastrointestinal surgeries

Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on screening laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

Subjects with a prior history of renal, liver or cardiac insufficiency

Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

Subjects undergoing colonoscopy for foreign body removal and/or decompression.

Subjects who are pregnant or lactating, or intending to become pregnant during the study.

Subjects of childbearing potential who refuse a pregnancy test.

Subjects allergic to any preparation components.

Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.

Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Subjects who withdraw consent before completion of Visit 1 procedures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01786629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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