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

• Sponsor: LG Life Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01624571
• Collaborator: (none)
• Enrollment: 147
• Location: 1
• Arms: 4
• Duration (Months): 7
• Patients Per Site Per Month: 20.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Resection; _large Interstinal Surgery	Drug: LD02GIFRO	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 147 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 300mg/day	Drug: LD02GIFRO; comparison of different dosages of drug
Experimental: Group 2 600mg/day	Drug: LD02GIFRO; comparison of different dosages of drug
Experimental: Group 3 900mg/day	Drug: LD02GIFRO; comparison of different dosages of drug
Placebo Comparator: Placebo Control Group	Drug: LD02GIFRO; comparison of different dosages of drug

Outcome Measures

Primary Outcome Measures

1. Improvement of gastrointestinal motility [in hospitalization (Maximized 14 days)]

   Evaluation gastrointestinal function to the time of improvement gastrointestinal motility

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan medical center	Seoul		Korea, Republic of	138-736

Sponsors and Collaborators

• LG Life Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LG Life Sciences
• ClinicalTrials.gov Identifier: NCT01624571
• Other Study ID Numbers: LG-GRCL001
• First Posted: Jun 20, 2012
• Last Update Posted: Feb 27, 2013
• Last Verified: Oct 1, 2012

Study Results

No Results Posted as of Feb 27, 2013