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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01624571
First received: June 7, 2012
Last updated: February 26, 2013
Last verified: October 2012
  Purpose

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 Intervention Phase
Colon Resection
_large Interstinal Surgery
Drug: LD02GIFRO
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Improvement of gastrointestinal motility [ Time Frame: in hospitalization (Maximized 14 days) ] [ Designated as safety issue: Yes ]
    Evaluation gastrointestinal function to the time of improvement gastrointestinal motility


Enrollment: 147
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624571

Locations
Korea, Republic of
Asan medical center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01624571     History of Changes
Other Study ID Numbers: LG-GRCL001
Study First Received: June 7, 2012
Last Updated: February 26, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014