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Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight

This study has been terminated.
(Low accrual rate.)
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00832520
First received: January 29, 2009
Last updated: October 29, 2013
Last verified: November 2012
Results First Received: July 20, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Advanced Cancer
Intervention: Drug: Remeron (mirtazapine)

  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
Enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible. The recruitment period spanned 07Apr2009 through 14Jul2010. All were recruited through the UNM Cancer Center medical clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Remeron (Mirtazapine) Mirtazapine 15 mg orally at bed time for 8 weeks

Participant Flow:   Overall Study
    Remeron (Mirtazapine)  
STARTED     13  
COMPLETED     13  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Remeron No text entered.

Baseline Measures
    Remeron  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     5  
Age  
[units: years]
Mean ± Standard Deviation
  59  ± 10  
Gender  
[units: participants]
 
Female     4  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     13  



  Outcome Measures

1.  Primary:   Change in Weight   [ Time Frame: 8 weeks ]

2.  Secondary:   To Determine if the Quality of Life Improves After Starting Mirtazapine   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Early termination leading to no subjects analyzed.There will be no publication, as this study was terminated after the original PI left employment with the institution.


  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: Nicole Stephens, PhD, CCRP, CRA
Organization: UNM Cancer Center
phone: 505-925-0350
e-mail: nstepehens@salud.unm.edu


No publications provided


Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00832520     History of Changes
Other Study ID Numbers: INST 0816
Study First Received: January 29, 2009
Results First Received: July 20, 2012
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board