NCT01624571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 27, 2013

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

June 7, 2012

Last Update Submit

February 26, 2013

Conditions

Colon Resection_large Interstinal Surgery

Outcome Measures

Primary Outcomes (1)

  • Improvement of gastrointestinal motility

    Evaluation gastrointestinal function to the time of improvement gastrointestinal motility

    in hospitalization (Maximized 14 days)

Study Arms (4)

Group 1

EXPERIMENTAL

300mg/day

Drug: LD02GIFRO

Group 2

EXPERIMENTAL

600mg/day

Drug: LD02GIFRO

Group 3

EXPERIMENTAL

900mg/day

Drug: LD02GIFRO

Placebo

PLACEBO COMPARATOR

Control Group

Drug: LD02GIFRO

Interventions

LD02GIFRODRUG

comparison of different dosages of drug

Group 1Group 2Group 3Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • Subject is scheduled for a total colectomy, colostomy, ileostomy
  • Subject has complete bowel obstruction
  • Subject is scheduled for laparoscopic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, 138-736, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 20, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 27, 2013

Record last verified: 2012-10

Locations

KR(1)