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Kristalose as Bowel Evacuant Prior to Colonoscopy

NCT ID: NCT01256541

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-09-30

Brief Summary

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To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas levels in patients requiring bowel evacuation, and also to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant

Detailed Description

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This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant prior to colonoscopy. Prior to colonoscopy, subjects will also undergo evaluation for the production of hydrogen and methane gases in the patient's gut (before and after receiving Kristalose) as assessed by a breath analysis instrument. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel).

Conditions

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Bowel Evacuant Prior to 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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Kristalose

Kristalose as Bowel Evacuant

Group Type EXPERIMENTAL

Kristalose

Intervention Type DRUG

The dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.

Interventions

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Kristalose

The dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients requiring bowel evacuation for colonoscopy

Exclusion Criteria

1. Patients with galactosemia (galactose-sensitive diet).
2. Patients known to be hypersensitive to any of the components of Kristalose.
3. Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
4. Patients less than 18 years of age.
5. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions.
6. Be pregnant or nursing
7. Be otherwise unsuitable for the study, in the opinion of the Investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Mason Hospital/Medical Center

OTHER

Sponsor Role collaborator

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Benaroya Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Virginia Mason Medical Center

Locations

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Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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IRB10068

Identifier Type: -

Identifier Source: org_study_id