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

LG Life Sciences

Status and phase: Completed; Phase 2

Conditions: Colon Resection; _large Interstinal Surgery

Treatments: Drug: LD02GIFRO

Study type: Interventional

Funder types: Industry

Identifiers

NCT01624571

LG-GRCL001

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

147 participants in 4 patient groups, including a placebo group

Group 1

Experimental group

Description:

300mg/day

Treatment:

Drug: LD02GIFRO

Group 2

Experimental group

Description:

600mg/day

Treatment:

Drug: LD02GIFRO

Group 3

Experimental group

Description:

900mg/day

Treatment:

Drug: LD02GIFRO

Placebo

Placebo Comparator group

Description:

Control Group

Treatment:

Drug: LD02GIFRO