NCT01533766

Brief Summary

The purpose of this study is to compare the safety and efficacy of CombiflexOmega in comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_3

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

August 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

5 months

First QC Date

January 18, 2012

Last Update Submit

February 15, 2013

Conditions

Parent

Outcome Measures

Primary Outcomes (1)

  • Comparison of adverse drug reaction

    6days

Secondary Outcomes (2)

  • Changes of laboratory parameters (biochemistry, hematology, coagulation)

    7days

  • Changes of vital signs

    7days

Study Arms (2)

CombiflexOmega

EXPERIMENTAL
Drug: CombiflexOmega

SmofKabiven

ACTIVE COMPARATOR
Drug: SmofKabiven

Interventions

CombiflexOmegaDRUG

intravenously over 5 days infusion

CombiflexOmega
SmofKabivenDRUG

intravenously over 5 days infusion

SmofKabiven

Eligibility Criteria

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

You may qualify if:

  • Patients aged 20 and older
  • Patients are expected to require PN for more than 5 days
  • Patients who voluntarily signed the consent form

You may not qualify if:

  • Patients are expected difficult to survive more than 5 days
  • Pregnant or breast-feeding women
  • BMI \> 30 kg/m2
  • Patients with severe blood coagulation disorders
  • Patients with congenital amino acid metabolism disorders
  • Patients with acute shock
  • Patients with uncontrollable diabetes mellitus
  • Patients with hemophage syndrome
  • Patients with hypopotassemia (K \< 3.0mEq/L)
  • Patients having the history of myocardial infarction
  • Patients reported the following laboratory value
  • fasting TG \> 250mg/dl, TC \> 300mg/dl
  • ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas)
  • Creatinine ≥ 1.5mg/dl
  • Ca \> 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

February 15, 2012

Study Start

August 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

KR(1)