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

June 7, 2012
February 26, 2013
March 2012
October 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01624571 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Assess the Effect on Recovery of GI Motility and Safety and to Determine the Optimal Dose of LD02GIFRO
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Colon Resection
  • _large Interstinal Surgery
Drug: LD02GIFRO
comparison of different dosages of drug
  • Experimental: Group 1
    300mg/day
    Intervention: Drug: LD02GIFRO
  • Experimental: Group 2
    600mg/day
    Intervention: Drug: LD02GIFRO
  • Experimental: Group 3
    900mg/day
    Intervention: Drug: LD02GIFRO
  • Placebo Comparator: Placebo
    Control Group
    Intervention: Drug: LD02GIFRO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01624571
LG-GRCL001
Yes
LG Life Sciences
LG Life Sciences
Not Provided
Not Provided
LG Life Sciences
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP