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Assessment of Pain in People With Thalassemia (Pain)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872339
First Posted: March 31, 2009
Last Update Posted: June 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes
Results First Submitted: 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
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ( U.S. NIH Grant/Contract )
First Submitted: March 30, 2009
First Posted: March 31, 2009
Results First Submitted: January 2, 2014
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014