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A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy

NCT01984008 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 631

Last updated 2020-03-30

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate that investigation medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An additional objective of this study is to collect subject's response to the acceptability and tolerability about bowel preparation and safety information.

After bowel preparation, independent evaluator who is blinded to subject's treatment will evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600 eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation to 1 of 2 treatment groups: "Bowklean" or "Klean-Prep" with Dulcolax. Each subject's participation is expected to be maximally 4 weeks in study duration (up to 3-week screening period followed by one week post colonoscopy).

Conditions

  • Bowel Preparation Before Colonoscopy

Interventions

DRUG

Picosulfate sodium, magnesium oxide, citric acid

Sponsors & Collaborators

  • Universal Integrated Corp.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-23
Primary Completion
2014-03-24
Completion
2014-06-17

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01984008 on ClinicalTrials.gov