- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00219310
RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
April 26, 2012 updated by: Novartis
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
East Hanover, New Jersey, United States
- Novartis Pharmaceuticals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (ACTUAL)
June 1, 2005
Study Completion (ACTUAL)
June 1, 2005
Study Registration Dates
First Submitted
September 21, 2005
First Submitted That Met QC Criteria
September 21, 2005
First Posted (ESTIMATE)
September 22, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
April 27, 2012
Last Update Submitted That Met QC Criteria
April 26, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Disease Attributes
- DNA Virus Infections
- Skin Diseases, Infectious
- Skin Diseases, Viral
- Herpesviridae Infections
- Recurrence
- Herpes Simplex
- Herpes Genitalis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Famciclovir
Other Study ID Numbers
- CFAM810AUS07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Genital Herpes (RGH)
-
UBP Greater China (Shanghai) Co., LtdNot yet recruiting
-
NovartisCompletedRecurrent Genital HerpesAustralia
-
UBP Greater China (Shanghai) Co., LtdNot yet recruiting
-
NanoBio CorporationCompletedRecurrent Herpes LabialisUnited States
-
University of ZurichDevirex AGCompleted
-
NovartisCompleted
-
Laboratoire Boreaderme Inc.Ecogene 21Unknown
-
EMSCompleted
-
Kaiser PermanentePatient-Centered Outcomes Research InstituteRecruitingMaternal Morbidity | Racial Disparities | Genital Herpes SimplexUnited States
-
NanoBio CorporationCompletedRecurrent Herpes Simplex LabialisUnited States
Clinical Trials on Famciclovir
-
NovartisCompletedFamciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster InfectionHerpes Zoster | ChickenpoxUnited States, Costa Rica, Guatemala, Panama
-
Roxane LaboratoriesCompleted
-
Roxane LaboratoriesCompleted
-
NovartisCompleted
-
Teva Pharmaceuticals USACompleted
-
Teva Pharmaceuticals USACompleted
-
Novartis PharmaceuticalsCompletedGenital HerpesUnited States, Germany, Australia, Canada
-
NovartisCompleted
-
NovartisCompletedRecurrent Genital HerpesAustralia
-
Novartis PharmaceuticalsCompletedHerpes SimplexUnited States, Panama