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

Information source: Cttq
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Zoster

Intervention: Foscarnet Sodium (Drug); Acyclovir (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Cttq

Overall contact:
Jianzhong Zhang, Doctor, Phone: 86-18610275899, Email: 13911815813@126.com

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

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Effective rate

Secondary outcome:

Incidence of Postherpetic neuralgia

number of participants with adverse event and serious adverse event

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Jianzhong Zhang, Doctor, Phone: 86-18610275899, Email: 13911815813@126.com

Peking University People's Hospital, Beijing, Beijing 100044, China; Not yet recruiting
Jianzhong Zhang, Doctor, Phone: 86-18610275899, Email: 13911815813@126.com
Jianzhong Zhang, Doctor, Principal Investigator
Additional Information

Starting date: May 2014
Last updated: May 28, 2014

Page last updated: August 23, 2015

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