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Assessment of Pain in People With Thalassemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00872339
First received: March 30, 2009
Last updated: May 27, 2014
Last verified: January 2014
Results First Received: January 2, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Thalassemia

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Transfusion-dependant People with transfusion-dependant thalassemia.
Intermittently Transfused Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
Non-transfusion-dependant People with non-transfusion-dependant thalassemia.

Participant Flow:   Overall Study
    Transfusion-dependant     Intermittently Transfused     Non-transfusion-dependant  
STARTED     201     14     37  
COMPLETED     201     14     37  
NOT COMPLETED     0     0     0  



  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.
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Reporting Groups
  Description
Transfusion-dependant People with transfusion-dependant thalassemia.
Intermittently Transfused Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
Non-transfusion-dependant People with non-transfusion-dependant thalassemia.
Total Total of all reporting groups

Baseline Measures
    Transfusion-dependant     Intermittently Transfused     Non-transfusion-dependant     Total  
Number of Participants  
[units: participants]
  201     14     37     252  
Age  
[units: years]
Mean ± Standard Deviation
  28.2  ± 10.4     35.8  ± 14.4     29.5  ± 16.2     28.8  ± 11.8  
Gender  
[units: participants]
       
Female     117     6     14     137  
Male     84     8     23     115  



  Outcome Measures
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1.  Primary:   Prevalence of Pain   [ Time Frame: Measured at Month 9 ]

2.  Secondary:   Common Sites of Pain   [ Time Frame: Measured at Month 9 ]

3.  Secondary:   Pain Occurrence by Age   [ Time Frame: Measured at Month 9 ]

4.  Secondary:   Impact of Pain on Functioning and Well-being   [ Time Frame: Measured at Month 9 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Felicia Trachtenberg
Organization: New England Research Institutes
phone: 6179723120
e-mail: ftrachtenberg@neriscience.com


Publications of Results:

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00872339     History of Changes
Other Study ID Numbers: 639, U01HL065238
Study First Received: March 30, 2009
Results First Received: January 2, 2014
Last Updated: May 27, 2014
Health Authority: United States: Federal Government