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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00248144
Other study ID # CFAM810A2403
Secondary ID
Status Completed
Phase Phase 4
First received November 2, 2005
Last updated December 7, 2007
Start date October 2003
Est. completion date July 2007

Study information

Verified date August 2006
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

The study is designed to assess the efficacy and safety of patient-initiated therapy with famciclovir 1500 mg o.d. or 750 mg b.i.d. for one day treatment in adult men and women with recurrent herpes labialis


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients aged 18 years or older

- A history typical for recurrent herpes labialis. The subject must have experienced three or more episodes of cold sores in the last 12 months, and have a history of prodromal symptoms, as defined by the patient, preceding at least 50% of these cold sores, and must also have a history of vesicular lesions in at least 50% of the recurrent episodes of cold sores.

- General good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's account of his/her medical history

- Women of child bearing potential had to use an accepted method of birth control (surgical sterilization; intra-uterine contraceptive device; oral contraceptives; hormone delivery systems such as NorplantĀ® or Depo-Provera injections; a diaphragm in combination with contraceptive cream, jelly, or foam; or a condom in combination with contraceptive cream, jelly or foam). Patients unable or unwilling to use one of the methods of birth control listed above for the duration of the study could not enter the study.

- For women of child-bearing potential, a negative pregnancy test (urine) at screening was required

- Signature on the informed consent document

Exclusion Criteria:

- Previous herpes vaccination

- Patients using topical immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) on or near the face or systemic immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) within 30 days of screening

- Patients known to be immunosuppressed due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy)

- Recent history of alcohol or drug abuse, which in the opinion of the investigator, could interfere with that study patient's compliance with study requirements

- Significant skin disease such as atopic dermatitis or eczema that would interfere with the assessment of lesions

- Allergy or hypersensitivity to formulations containing acyclovir, penciclovir, famciclovir, and/or other nucleoside analogues

- Women who were lactating or breast feeding

- Had already been randomized once into the study

- Patients who had received an investigational drug in the past four weeks

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Famciclovir


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Outcome

Type Measure Description Time frame Safety issue
Primary Time to healing of the primary lesion complex (loss of crust from vesicular [classical] lesions)
Secondary safety and tolerability assessed by adverse events (AEs)
Secondary resolution of pain / discomfort after short-course regimens
Secondary proportion of patients with aborted lesions
Secondary time to healing of all vesicular lesions
Secondary time to healing of all aborted (non-vesicular) lesions
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03977792 - An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis Phase 2
Active, not recruiting NCT05098938 - A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally Phase 3
Completed NCT01985321 - Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores Phase 2
Completed NCT03192306 - Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores Phase 2
Completed NCT01324466 - A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS) Phase 3
Completed NCT00914745 - Place Controlled Study to Treat Recurrent Herpes Labialis. Phase 2