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OpenTrials
Completed

NCT Number: NCT01624571

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

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.

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Key information

Conditions

Colon Resection _large Interstinal Surgery

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan medical center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LD02GIFRO

Drug

comparison of different dosages of drug

Primary outcomes

  1. Improvement of gastrointestinal motility

    Time frame: in hospitalization (Maximized 14 days)

    Evaluation gastrointestinal function to the time of improvement gastrointestinal motility

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2012
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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