NCT00144482

Brief Summary

To evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy

Trial Health

100
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2003

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

December 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

February 2, 2009

Status Verified

January 1, 2009

Enrollment Period

1.2 years

First QC Date

September 2, 2005

Last Update Submit

January 29, 2009

Conditions

Chemotherapy Induced Anemia

Outcome Measures

Primary Outcomes (1)

  • The increase in Hb concentration

    week 8

Secondary Outcomes (1)

  • Changes in QOL scores

    8 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: recombinant human erythropoietin

2

PLACEBO COMPARATOR
Drug: recombinant human erythropoietin placebo

Interventions

recombinant human erythropoietinDRUG

36000IU（0.5mL）s.c./week for 8 weeks

1
recombinant human erythropoietin placeboDRUG

0 IU(0.5mL)s.c./week for 8 weeks

2

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer patients

You may not qualify if:

  • a history of myocardial, cerebral or pulmonary infarction
  • severe hypertension beyond control by drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yoshiharu Ishikura

    Chugai Pharmaceutical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

December 1, 2003

Primary Completion

March 1, 2005

Study Completion

August 1, 2005

Last Updated

February 2, 2009

Record last verified: 2009-01