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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01624571

Enrollment

147

Registered

2012-06-20

Start date

2012-03-31

Completion date

2012-10-31

Last updated

2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Resection, _large Interstinal Surgery

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.

Interventions

DRUGLD02GIFRO

comparison of different dosages of drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026