Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
  Hide More Information

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


No publications provided


Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210626     History of Changes
Other Study ID Numbers: CR003235, LTTO;, Long Term Treatment Outcomes;, PR04-15-001
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