This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH...
Date First Received: September 21, 2005
Last Updated: August 23, 2006
Verified by: Novartis, August 2006
Clinical Trial Phase: Phase 4 | Start Date: June 2003
Overall Status: Completed
Brief Summary
Official Title: “A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction”
Condition Keyword(s):
Intervention(s):
This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Famciclovir
Outcome Measures for this Clinical Trial
Primary Measures
- Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
Secondary Measures
- Change in total score of the Recurrent Genital Herpes Quality of Life.
- Safety assessed by adverse events.
- Time to first recurrence of genital herpes.
- Number of genital herpes recurrences confirmed by PCR.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- • Patients who are immunocompetent and who have had 4 or more episodes of Recurrent
- Genital Herpes (RGH) in the last 12 months.
- Patients with active HSV-2 or HSV-1 infection as confirmed by Polymerase Chain
- Reaction (PCR).
- Patients with active symptoms (i.e., itching, burning, tingling, aching, tenderness, rash or pain) associated with a recurrent episode of genital herpes
Exclusion Criteria:
- • Female patients who are pregnant or breast-feeding.
- Current, history or suspicion of liver disease or kidney disease.
- HIV infected (as confirmed by positive HIV serology).
- Other protocol-defined inclusion/exclusion criteria may apply.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Chair Novartis
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00219310
Study ID Number: CFAM810AUS07
ClinicalTrials.gov Identifier: NCT00219310
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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