Health TrialsbyHealthPanel

A Study to Evaluate Safety and Efficacy of PBK_M2502

ConditionsIntestinal DiseaseColonic DiseasesGastrointestinal DiseaseDigestive System Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorPharmbio Korea Co., Ltd.

About this trial

This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients who is informed and give a consent in voluntary

Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy

BMI 19≤and<30

Disqualifiers

Patients who participate in other interventional study or had participated within 30 days before screening

Pregnant or breast-feeding women who do not want to stop breast-feeding

Uncontrolled hypertension

Uncontrolled diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • PBK_M2502 1-Day

    Drug

    Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.

  • PBK_M2502 2-Day

    Drug

    Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: active ComparatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Successful cleansing rate

%Patient with HCS-graded A or B

Time frame
Day 1 (day of colonoscopy)

Secondary outcomes

1

Overall cleansing rate

%Patient with each HCS-grade (A, B, C, D)

Time frame
Day 1 (day of colonoscopy)
2

Mean segmental cleansing score

5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.

Time frame
Day 1 (day of colonoscopy)
3

Mean cecal intubation time

Time frame
Day 1 (day of colonoscopy)
4

Mean colonoscopy withdrawal time

Time frame
Day 1 (day of colonoscopy)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharmbio Korea Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: