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Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Boston Children’s Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00686855
First received: May 27, 2008
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: November 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Oral Chronic Graft-versus-host Disease
Interventions: Drug: Tacrolimus
Drug: Dexamethasone

  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
Dexamethasone Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
Tacrolimus

Tacrolimus Arm Closed to Accrual as of January 2012

Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks


Participant Flow:   Overall Study
    Dexamethasone   Tacrolimus
STARTED   28   18 
COMPLETED   27   17 
NOT COMPLETED   1   1 
Lost to Follow-up                1                0 
Progressive GVHD                0                1 



  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
Dexamethasone Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
Tacrolimus

Tacrolimus Arm Closed to Accrual as of January 2012

Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks

Total Total of all reporting groups

Baseline Measures
   Dexamethasone   Tacrolimus   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   18   46 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   22   12   34 
>=65 years   6   6   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.8  (11.5)   54.9  (15.3)   54.2  (13) 
Gender 
[Units: Participants]
     
Female   17   6   23 
Male   11   12   23 
Region of Enrollment 
[Units: Participants]
     
United States   28   18   46 


  Outcome Measures

1.  Primary:   The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.   [ Time Frame: Participants were assessed at Baseline and 4 weeks after start of therapy ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nathaniel S. Treister, DMD, DMSc
Organization: Dana-Farber Cancer Institute
phone: 617-632-2806
e-mail: ntreister@partners.org



Responsible Party: Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00686855     History of Changes
Other Study ID Numbers: 08-027
Study First Received: May 27, 2008
Results First Received: November 20, 2013
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board