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Completed

NCT Number: NCT02151240

Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection in Patients With Herpes Zoster

The purpose of this study is to evaluate the efficacy and safety of Foscarnet Sodium and Sodium Chloride Injection in patients with herpes zoster, and observe incidence of Postherpetic neuralgia

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.Patients with clinical diagnosis of Herpes Zoster, and able to be enrolled into the study ≤ 72 hours from appearance of rash; 2.18-65 years old, men and women; 3.VAS score≥4; 4.Patients haven't receive any antiviral medication before enrollment; 5.Patients able to understand the study procedures, agree to participate and give written consent.

Exclusion criteria

  • Patients with history of allergy to Foscarnet Sodium or Acyclovir;
  • Other combined infection (bacteria, fungi)
  • Severe decline in immune function, or long-term use of corticosteroid and immunosuppressor
  • Serious liver or renal function abnormalities (Aspartate Transaminase(AST) or alanine transaminase(ALT) ≥ 2.5x upper limits of normal(ULN), Creatinine(Cr) or Blood urea nitrogen(BUN)≥ 1x ULN)
  • Women who are pregnant or lactating, and women of childbearing potential failed to use an adequate method of contraception to avoid pregnancy;
  • Patients using other antiviral drugs;
  • Long-term use of non-steroid anti-inflammatory drug, tricyclic antidepressant, anti-epileptic drugs or analgesic
  • Current malignant tumor;
  • Patients investigators consider as inappropriate to participate in the study

Treatment and study plan

Foscarnet sodium

Drug

Acyclovir

Drug

Primary outcomes

  1. Effective rate

    Time frame: 8th days

    Effective rate = (No. of patients achieving recovery+ markedly improvement)/Total patients No.×100%.

    Recovery: curative index≥90%; Markedly improved: curative index 60%-89%; Improved: curative index 20%-59%; Ineffective: curative index<20%. Where Curative Index= (patient's pre-treatment condition score - post-treatment condition score)/pre-treatment condition score ×100%

Secondary outcomes

  1. Incidence of Postherpetic neuralgia

    Time frame: 3rd month

  2. number of participants with adverse event and serious adverse event

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Cttq

Industry

Collaborators

  • Peking University People's Hospital

Registry information

Official study title

A Multi-centered, Randomized Study to Evaluate the Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection Compared to Intravenous Acyclovir in Patients With Herpes Zoster From China

Acronym: Focus-101

Important dates

Study start
2014
Primary completion
2015
Study completion
2019
First posted
May 30, 2014
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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