Trial Outcomes & Findings for Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes (NCT NCT01281007)

NCT ID: NCT01281007

Last Updated: 2021-04-21

Results Overview

Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 150 participants
• Primary outcome timeframe: Day 5
• Results posted on: 2021-04-21

Participant Flow

Participant milestones

Measure	Famciclovir 125 mg 1 tablet every 12 hours for 5 days Famciclovir: Famciclovir 125 mg every 12 hours for 5 days	Aciclovir 200 mg 1 tablet every 4 hours (excluding nocturnal dose) for 5 days Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days
Overall Study STARTED	75	75
Overall Study COMPLETED	71	67
Overall Study NOT COMPLETED	4	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Famciclovir 125 mg n=75 Participants 1 tablet every 12 hours for 5 days Famciclovir: Famciclovir 125 mg every 12 hours for 5 days	Aciclovir 200 mg n=75 Participants 1 tablet every 4 hours (excluding nocturnal dose) for 5 days Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=93 Participants	73 Participants n=4 Participants	143 Participants n=27 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Female	57 Participants n=93 Participants	50 Participants n=4 Participants	107 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	25 Participants n=4 Participants	43 Participants n=27 Participants
Region of Enrollment Brazil	75 participants n=93 Participants	75 participants n=4 Participants	150 participants n=27 Participants

PRIMARY outcome

Timeframe: Day 5

Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.

Outcome measures

Measure	Famciclovir 125 mg n=75 Participants 1 tablet every 12 hours for 5 days Famciclovir: Famciclovir 125 mg every 12 hours for 5 days	Aciclovir 200 mg n=75 Participants 1 tablet every 4 hours (excluding nocturnal dose) for 5 days Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation	73 subjects	52 subjects

SECONDARY outcome

Timeframe: Day 5

Adverse events will be collected and followed in order to evaluate safety and tolerability

Outcome measures

Outcome data not reported

Adverse Events

Famciclovir 125 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Aciclovir 200 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Famciclovir 125 mg n=75 participants at risk 1 tablet every 12 hours for 5 days Famciclovir: Famciclovir 125 mg every 12 hours for 5 days	Aciclovir 200 mg n=75 participants at risk 1 tablet every 4 hours (excluding nocturnal dose) for 5 days Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days
Nervous system disorders Headache	13.3% 10/75 • Number of events 10	16.0% 12/75 • Number of events 12

Additional Information

Manager of Clinical Trials

EMS

Phone: +5501938874176

Email: pesquisa.clinica@ems.com.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place