A Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel, Phase II Clinical Trial to Assess the Effect on Recovery of GI Motility and Safety and to Determine the Optimal Dose of LD02GIFRO in Patients Undergoing Colon Resection

LG Life Sciences1 site in 1 country147 target enrollmentMarch 2012

ConditionsColon Resection _large Interstinal Surgery

InterventionsLD02GIFRO

DrugsLD02GIFRO

Overview

Phase: Phase 2
Intervention: LD02GIFRO
Conditions: Colon Resection
Sponsor: LG Life Sciences
Enrollment: 147
Locations: 1
Primary Endpoint: Improvement of gastrointestinal motility
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

October 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

LG Life Sciences

Responsible Party

Sponsor

Eligibility Criteria

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