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Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection in Patients With Herpes Zoster (Focus-101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02151240
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : June 28, 2021
Sponsor:
Collaborator:
Peking University People's Hospital
Information provided by (Responsible Party):
Cttq

Study Description
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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

Condition or disease Intervention/treatment Phase
Herpes Zoster Drug: Foscarnet Sodium Drug: Acyclovir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Foscarnet Sodium and Sodium Chloride Injection 3g: 250ml, IV; Second administration: Foscarnet Sodium and Sodium Chloride Injection 3g: 250ml, IV
 Drug: Foscarnet Sodium
Active Comparator: Arm II
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
 Drug: Acyclovir


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151240


Locations
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China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Cttq
Peking University People's Hospital
More Information
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Publications of Results:

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Responsible Party: Cttq
ClinicalTrials.gov Identifier: NCT02151240    
Other Study ID Numbers: cttq-focus-101
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Keywords provided by Cttq:
herpes zoster, Foscarnet Sodium, Acyclovir, Postherpetic neuralgia
Additional relevant MeSH terms:
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Herpes Simplex
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Varicella Zoster Virus Infection
 Acyclovir
Foscarnet
Phosphonoacetic Acid
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action