NCT01742013

Brief Summary

GCJBP Laennec Injection contains a variety of cytokines derived from human placenta, amino acids, peptides, nucleobases, and carbohydrates. This product is approved for improving liver function. Also, it has been prescribed for lots of diseases such as menopausal disorders, atopic dermatitis, skin cares as well as fatigue for long time. Although its action mechanism and clinical effectiveness are not still clear, there are reports which say a strong probability of its clinical effectiveness in the chronic fatigue patients. This study aims to investigate the safety and efficacy of GCJBP Laennec Inj. (Human placenta hydrolysate) in the chronic fatigue patients through a randomized controlled tial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

7 months

First QC Date

November 29, 2012

Last Update Submit

September 24, 2013

Conditions

Chronic Fatigue SyndromeIdiopathic Chronic Fatigue

Keywords

Chronic FatigueCFSICFhuman placenta

Outcome Measures

Primary Outcomes (1)

  • Change of Fatigue Severity Scale (FSS)

    Baseline and 6 weeks

Secondary Outcomes (10)

  • Change per item of Fatigue Severity Scale (FSS)

    Baseline, 3, 6 and 9 weeks

  • Rate of patients whose FSS decreased from 4 and more to less than 4

    Baseline, 3, 6 and 9 weeks

  • Change of Visual Analogue Scale (VAS)

    Baseline, 3 and 6 weeks

  • Change of Multidimensional Fatigue Inventory (MFI)

    Baseline, 3 and 6 weeks

  • Global Improvement Scale (GIS)

    6 weeks

  • +5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks

Drug: Placebo

GCJBP Laennec Inj.

EXPERIMENTAL

GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks

Drug: GCJBP Laennec Inj.

Interventions

GCJBP Laennec Inj.DRUG

Test drug

Also known as: Human placenta hydrolysate
GCJBP Laennec Inj.
PlaceboDRUG

Comparator

Also known as: Normal saline solution (NaCl 0.9%)
Placebo

Eligibility Criteria

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

You may qualify if:

  • Patient diagnosed with chronic fatigue syndrome or idiopathic chronic fatigue
  • Given written informed consent
  • Male or female aged between 20 and 65
  • Patient who can read and answer to written questionnaires
  • Patient who agrees to visit clinic for study drug injection 3 times per a week for 6 weeks

You may not qualify if:

  • Patient who has been administrated with any other investigational product for 28 days prior to screening visit
  • Patient who is pregnant or childbearing potential female patient who does not consent for contraception during the study
  • Patient who has a hypersensitivity provoked by study drug or others drived from animals
  • Patient who has been received with any human placenta product for 6 months before study participation
  • Abnormal liver function
  • Abnormal renal function
  • Back Depression Inventory (BDI) II is more than 29
  • Underlying disease/conditions, in the investigator's judgment, which will be unable to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ho Cheol Shin, M.D., Ph.d.

    Kangbuk Samsung Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 5, 2012

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

KR(2)