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

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

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)

Clinical Trials on Famciclovir

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