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

Taejoon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Bowel Preparation

Treatments: Drug: Coolprep powder; Drug: TJP-008-2; Drug: TJP-008-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03544944

TJP-008-301

Details and patient eligibility

About

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

Enrollment: 297 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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297 participants in 3 patient groups

TJP-008-1

Experimental group

Treatment:

Drug: TJP-008-1

TJP-008-2

Experimental group

Treatment:

Drug: TJP-008-2

Coolprep powder

Active Comparator group

Treatment:

Drug: Coolprep powder