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Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa

This study has been terminated.
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210626
First received: September 13, 2005
Last updated: April 2, 2014
Last verified: April 2014
Results First Received: June 26, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Anemia
Interventions: Drug: PROCRIT
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
ITT subjects were all randomized subjects. Three subjects were randomized prior to screening and failed screening. These 3 subjects did not receive any study medication or procedure prior to discontinuation and are not included in the 192 subjects that started the study.

Reporting Groups
  Description
PROCRIT 40,000 IU/mL/week for maximum of 12 weeks
Placebo Placebo given at equivalent volume (1 mL) as Procrit

Participant Flow:   Overall Study
    PROCRIT   Placebo
STARTED   97   95 
COMPLETED   49   50 
NOT COMPLETED   48   45 
Adverse Event                1                2 
Protocol Violation                1                5 
Lost to Follow-up                11                11 
Death                1                0 
Withdrawal by Subject                29                20 
Physician Decision                0                2 
Sponser Request                1                0 
Not Specified                4                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PROCRIT 40,000 IU/mL/week for maximum of 12 weeks
Placebo Placebo given at equivalent volume (1 mL) as Procrit
Total Total of all reporting groups

Baseline Measures
   PROCRIT   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 96   92   188 
Age 
[Units: Participants]
     
<=18 years   7   3   10 
Between 18 and 65 years   89   89   178 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.2  (10.94)   33.5  (11.06)   32.8  (10.99) 
Gender 
[Units: Participants]
     
Female   32   35   67 
Male   64   57   121 


  Outcome Measures
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1.  Primary:   SF-36 PF Score   [ Time Frame: Hospital Discharge to Post-Hospital Discharge Week 24 ]

2.  Secondary:   Return to Usual Activity (RTUA)   [ Time Frame: Hospital Discharge to Post-Hospital Discharge Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was stopped early due to slow enrollment. Four subjects were randomized but withdrew prior to hospital entry and no data were collected


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President Medical Affairs
Organization: Centocor Ortho Biotech Services, LLC (COBS)
phone: 215-325-4464



Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210626     History of Changes
Other Study ID Numbers: CR003235
LTTO; ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
Long Term Treatment Outcomes; ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
PR04-15-001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
Study First Received: September 13, 2005
Results First Received: June 26, 2009
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration