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

Phase 4

Completed

• Conditions: Herpes Zoster
• Interventions: Drug: Foscarnet Sodium; Drug: Acyclovir

• Registration Number: NCT02151240
• Lead Sponsor: Cttq

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-30
• Primary Completion: 2015-05
• Study Completion: 2019-07
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	Foscarnet Sodium	Foscarnet Sodium and Sodium Chloride Injection 3g: 250ml, IV; Second administration: Foscarnet Sodium and Sodium Chloride Injection 3g: 250ml, IV
Arm II	Acyclovir	First administration: Acyclovir for Injection 0.25g + 0.9% Sodium Chloride Injection 250ml, IV; Acyclovir for Injection 0.25g + 0.9% Sodium Chloride Injection 250ml, IV; Second administration: Acyclovir for Injection 0.25g+ 0.9% Sodium Chloride Injection 250ml, IV

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China