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OpenTrials
Completed

NCT Number: NCT03544944

A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy

This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

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Key information

Conditions

Bowel Preparation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients must provide written informed consent.
  • Male and female outpatients and inpatients aged: ≥19
  • Patients BMI shoule be ≤ 30

Exclusion criteria

  • Patients with past history within last 12 months or current episode of severe constipation
  • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Known phenylketonuria.
  • Clinically relevant findings on physical examination based on the Investigator's judgment.

Treatment and study plan

TJP-008-1

Drug

Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.

TJP-008-2

Drug

Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.

Coolprep powder

Drug

Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning.

Primary outcomes

  1. Ratio of subjects With successful Bowel Cleansing

    Time frame: 1 day of scheduled colonoscopy

Secondary outcomes

  1. Easch segments ratio of subject with successful Bowel Cleansing

    Time frame: 1 day of scheduled colonoscopy

Sponsors and collaborators

Lead sponsor

Taejoon Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Sep 4, 2019

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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