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Trial record 35 of 113 for:    acyclovir

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

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ClinicalTrials.gov Identifier: NCT02151240
Recruitment Status : Unknown
Verified May 2014 by Cttq.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2014
Last Update Posted : May 30, 2014
Sponsor:
Collaborator:
Peking University People's Hospital
Information provided by (Responsible Party):
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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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
Estimated Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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



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 ]


Information from the National Library of Medicine

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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

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


Contacts
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Contact: Jianzhong Zhang, Doctor 86-18610275899 13911815813@126.com

Locations
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China, Beijing
Peking University People's Hospital Not yet recruiting
Beijing, Beijing, China, 100044
Contact: Jianzhong Zhang, Doctor    86-18610275899    13911815813@126.com   
Principal Investigator: Jianzhong Zhang, Doctor         
Sponsors and Collaborators
Cttq
Peking University People's Hospital

Publications of Results:
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Responsible Party: Cttq
ClinicalTrials.gov Identifier: NCT02151240     History of Changes
Other Study ID Numbers: cttq-focus-101
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by Cttq:
herpes zoster, Foscarnet Sodium, Acyclovir, Postherpetic neuralgia

Additional relevant MeSH terms:
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Acyclovir
Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Foscarnet
Phosphonoacetic Acid
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents