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Trial record 15 of 115 for:    acyclovir

Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes

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ClinicalTrials.gov Identifier: NCT01281007
Recruitment Status : Completed
First Posted : January 21, 2011
Results First Posted : July 7, 2015
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):
EMS

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition GENITAL HERPES
Interventions Drug: Famciclovir
Drug: Aciclovir
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Famciclovir 125 mg Aciclovir 200 mg
Hide Arm/Group Description

1 tablet every 12 hours for 5 days

Famciclovir: Famciclovir 125 mg every 12 hours for 5 days

1 tablet every 4 hours (excluding nocturnal dose) for 5 days

Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days

Period Title: Overall Study
Started 75 75
Completed 71 67
Not Completed 4 8
Arm/Group Title Famciclovir 125 mg Aciclovir 200 mg Total
Hide Arm/Group Description

1 tablet every 12 hours for 5 days

Famciclovir: Famciclovir 125 mg every 12 hours for 5 days

1 tablet every 4 hours (excluding nocturnal dose) for 5 days

Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days

Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
70
  93.3%
73
  97.3%
143
  95.3%
>=65 years
5
   6.7%
2
   2.7%
7
   4.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
57
  76.0%
50
  66.7%
107
  71.3%
Male
18
  24.0%
25
  33.3%
43
  28.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 75 participants 75 participants 150 participants
75 75 150
1.Primary Outcome
Title Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
Hide Description Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Time Frame Day 5
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Famciclovir 125 mg Aciclovir 200 mg
Hide Arm/Group Description:

1 tablet every 12 hours for 5 days

Famciclovir: Famciclovir 125 mg every 12 hours for 5 days

1 tablet every 4 hours (excluding nocturnal dose) for 5 days

Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days

Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: subjects
73 52
2.Secondary Outcome
Title Safety Will be Evaluated by the Adverse Events Occurence
Hide Description Adverse events will be collected and followed in order to evaluate safety and tolerability
Time Frame Day 5
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Famciclovir 125 mg Aciclovir 200 mg
Hide Arm/Group Description

1 tablet every 12 hours for 5 days

Famciclovir: Famciclovir 125 mg every 12 hours for 5 days

1 tablet every 4 hours (excluding nocturnal dose) for 5 days

Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days

All-Cause Mortality
Famciclovir 125 mg Aciclovir 200 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Famciclovir 125 mg Aciclovir 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/75 (0.00%)      0/75 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Famciclovir 125 mg Aciclovir 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/75 (13.33%)      12/75 (16.00%)    
Nervous system disorders     
Headache   10/75 (13.33%)  10 12/75 (16.00%)  12
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Manager of Clinical Trials
Organization: EMS
Phone: +5501938877776
EMail: pesquisa.clinica@ems.com.br
Layout table for additonal information
Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01281007     History of Changes
Other Study ID Numbers: F125EMS1010
First Submitted: January 20, 2011
First Posted: January 21, 2011
Results First Submitted: May 29, 2015
Results First Posted: July 7, 2015
Last Update Posted: July 7, 2015