CompletedNCT01624571Updated Feb 27, 2013

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

A Phase 2 interventional study of LD02GIFRO in Colon Resection and _large Interstinal Surgery, sponsored by LG Life Sciences. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-02-27.

Sponsored by LG Life Sciences · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 147
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study 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.

Conditions studied

Colon Resection
_large Interstinal Surgery

In context

Lead sponsor

LG Life Sciences is the lead sponsor of 75 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: 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

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 147 participants (actual)

Study arms

Experimental
Group 1
300mg/day
Drug: LD02GIFRO
Experimental
Group 2
600mg/day
Drug: LD02GIFRO
Experimental
Group 3
900mg/day
Drug: LD02GIFRO
Placebo comparator
Placebo
Control Group
Drug: LD02GIFRO

Interventions

DrugLD02GIFRO
comparison of different dosages of drug

What researchers measure

Primary outcomes

Improvement of gastrointestinal motility
Evaluation gastrointestinal function to the time of improvement gastrointestinal motility
Time frame: in hospitalization (Maximized 14 days)

Study locations

1 site

Asan medical center
Seoul, 138-736, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01624571
Lead sponsor: LG Life Sciences
Responsible party: Sponsor
First posted: Jun 20, 2012
Start date: Mar 2012
Primary completion: Oct 2012
Completion: Oct 2012
Last update: Feb 27, 2013

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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