A Study to Evaluate the Safety and Efficacy of Single Day or Single Dose Famciclovir for the Treatment of Recurrent Herpes Labialis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00248144
First received: November 2, 2005
Last updated: December 7, 2007
Last verified: August 2006
  Purpose

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


Condition Intervention Phase
Recurrent Herpes Labialis
Drug: Famciclovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blinded Controlled Study to Compare the Effectiveness of a Single Dose (1500 mg) of Famciclovir, One Day (750 mg q12) of Famciclovir and Placebo in Patient-Initiated Episodic Treatment of Recurrent Herpes Labialis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time to healing of the primary lesion complex (loss of crust from vesicular [classical] lesions)

Secondary Outcome Measures:
  • safety and tolerability assessed by adverse events (AEs)
  • resolution of pain / discomfort after short-course regimens
  • proportion of patients with aborted lesions
  • time to healing of all vesicular lesions
  • time to healing of all aborted (non-vesicular) lesions

Study Start Date: October 2003
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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 Norplant® 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248144

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00248144     History of Changes
Other Study ID Numbers: CFAM810A2403
Study First Received: November 2, 2005
Last Updated: December 7, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
Herpes labialis

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Famciclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014