Study to Assess the Effect on Recovery of GI Motility and Safety and to Determine the Optimal Dose of LD02GIFRO

NCT ID: NCT01624571

Last Updated: 2013-02-27

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

PHASE2

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-10-31

Brief Summary

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This clinical trial is conducted to determine the optimal dose of LD02GIFRO in improvement of gastrointestinal motility between each dose group by comparing the effectiveness and safety in patients undergoing colon resection.

Detailed Description

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Conditions

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Colon Resection _large Interstinal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

300mg/day

Group Type EXPERIMENTAL

LD02GIFRO

Intervention Type DRUG

comparison of different dosages of drug

Group 2

600mg/day

Group Type EXPERIMENTAL

LD02GIFRO

Intervention Type DRUG

comparison of different dosages of drug

Group 3

900mg/day

Group Type EXPERIMENTAL

LD02GIFRO

Intervention Type DRUG

comparison of different dosages of drug

Placebo

Control Group

Group Type PLACEBO_COMPARATOR

LD02GIFRO

Intervention Type DRUG

comparison of different dosages of drug

Interventions

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LD02GIFRO

comparison of different dosages of drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥ 20 years
* Subject is scheduled for a partial colon resection with primary anastomosis via laparotomy
* Subject is scheduled to receive primary postoperative pain management with intravenous patient-controlled analgesia (PCA) opioids

Exclusion Criteria

* Subject is scheduled for a total colectomy, colostomy, ileostomy
* Subject has complete bowel obstruction
* Subject is scheduled for laparoscopic surgery
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asan medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LG-GRCL001

Identifier Type: -

Identifier Source: org_study_id

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