Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection (Mono6)

This study has been completed.
Sponsor:
Collaborator:
Epiphany Biosciences
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00575185
First received: December 14, 2007
Last updated: March 13, 2015
Last verified: March 2015
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infectious Mononucleosis
Interventions: Drug: Valomaciclovir
Drug: placebo

  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
University of Minnesota students that contracted Mono and wsere seen at the student health center

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
Valomaciclovir

Valomaciclovir 2 grams orally twice daily for 21 days

Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.

Placebo

placebo 2 tablets twice daily for 21 days

placebo : Placebo tablets orally twice daily for 21 days.


Participant Flow:   Overall Study
    Valomaciclovir     Placebo  
STARTED     12     11  
COMPLETED     12     11  
NOT COMPLETED     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.
College students infected with mono

Reporting Groups
  Description
Valomaciclovir

Valomaciclovir 2 grams orally twice daily for 21 days

Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.

Placebo

placebo 2 tablets twice daily for 21 days

placebo : Placebo tablets orally twice daily for 21 days.

Total Total of all reporting groups

Baseline Measures
    Valomaciclovir     Placebo     Total  
Number of Participants  
[units: participants]
  12     11     23  
Age  
[units: particpants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     11     23  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     5     5     10  
Male     7     6     13  
Region of Enrollment  
[units: participants]
     
United States     12     11     23  



  Outcome Measures
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1.  Primary:   Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline   [ Time Frame: 21 days ]

2.  Secondary:   Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability   [ Time Frame: 15 days ]


  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: Hank Balfour MD
Organization: University of Minnesota
phone: (612) 626-5670
e-mail: balfo001@umn.edu


Publications:


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00575185     History of Changes
Other Study ID Numbers: 0709M16341
Study First Received: December 14, 2007
Results First Received: December 3, 2014
Last Updated: March 13, 2015
Health Authority: United States: Food and Drug Administration