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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02151240

Acronym

Focus-101

Enrollment

Registered

2014-05-30

Start date

2014-05-31

Completion date

2019-07-31

Last updated

2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster

Keywords

herpes zoster, Foscarnet Sodium, Acyclovir, Postherpetic neuralgia

Brief summary

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

Interventions

DRUGFoscarnet Sodium

DRUGAcyclovir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

1. Patients with history of allergy to Foscarnet Sodium or Acyclovir; 2. Other combined infection (bacteria, fungi) 3. Severe decline in immune function, or long-term use of corticosteroid and immunosuppressor 4. 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) 5. Women who are pregnant or lactating, and women of childbearing potential failed to use an adequate method of contraception to avoid pregnancy; 6. Patients using other antiviral drugs; 7. Long-term use of non-steroid anti-inflammatory drug, tricyclic antidepressant, anti-epileptic drugs or analgesic 8. Current malignant tumor; 9. Patients investigators consider as inappropriate to participate in the study

Design outcomes

Primary

Measure	Time frame	Description
Effective rate	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

Measure	Time frame
Incidence of Postherpetic neuralgia	3rd month
number of participants with adverse event and serious adverse event	up to 3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026