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

Phase 2

Completed

• Conditions: Colon Resection; _large Interstinal Surgery
• Interventions: Drug: LD02GIFRO

• Registration Number: NCT01624571
• Lead Sponsor: LG Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	LD02GIFRO	300mg/day
Group 2	LD02GIFRO	600mg/day
Group 3	LD02GIFRO	900mg/day
Placebo	LD02GIFRO	Control Group

Primary Outcome Measures

Name	Time	Method
Improvement of gastrointestinal motility	in hospitalization (Maximized 14 days)	Evaluation gastrointestinal function to the time of improvement gastrointestinal motility

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of