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

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ClinicalTrials.gov Identifier: NCT01624571
Recruitment Status : Completed
First Posted : June 20, 2012
Last Update Posted : February 27, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colon Resection _large Interstinal Surgery Drug: LD02GIFRO Phase 2

Study Type : Interventional  (Clinical Trial)
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 : March 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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



Primary Outcome Measures :
  1. Improvement of gastrointestinal motility [ Time Frame: in hospitalization (Maximized 14 days) ]
    Evaluation gastrointestinal function to the time of improvement gastrointestinal motility



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624571


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

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01624571     History of Changes
Other Study ID Numbers: LG-GRCL001
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: October 2012