CTRI/2009/091/000044CompletedPhase 3
A Phase III, Multicenter, Randomized, Open Label, Active Controlled, Parallel Group Study To Compare The Safety And Efficacy Of Acyclovir 1200 mg -Sustained Release With Acyclovir 800 mg- Immediate Release In Immunocompetent Patients With Uncomplicated Herpes Zoster.
FDC Limited,142-148, S.V.Road, Jogeshwari (W), Mumbai - 400102, Maharashtra, India0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Written informed consent from the subject.
- •2. Age above 18 years inclusive.
- •3. Diagnosis of herpes zoster clinically verified by
- •a physician.
- •4. Presenting within 72 hrs of onset of a localized
- •herpes zoster rash.
Exclusion Criteria
- •1. Subjects with any condition which in the opinion
- •of the investigator makes the subject unsuitable for
- •2. Complication of herpes zoster: ocular and visceral
- •involvement, motor neuropathies, encephalitis,
- •cerebrovascular complications, Severe
- •disseminated infection: (more than 20 lesions
- •outside the primary affected dermatome).
- •3. Subjects receiving chronic steroid therapy,
- •immunosuppressive therapy, chemotherapy for
- •malignancy.
- •4. HIV positive individual.
- •5. Subjects with autoimmune disorder.
- •6. SGOT and SGPT >/= 2 times the upper limit of
- •7. Serum creatinine >/= 2 times the upper limit of
- •8. Subject is a female who is pregnant or willing to
- •get pregnant, not ready to use contraceptive
- •measures during the trial period or breast feeding.
- •9. Subject has a history of medical illness that may affect the study outcome.
- •10. Known hypersensitivity to Acyclovir.
- •11. Subject with any Gastrointestinal disorder.
- •12. Subject who is consuming/ has received antiviral
- •drugs during last 60 days.
- •13. Subject who is consuming/ has received.
- •immunomodulators during last 60 days.
- •14. Subject who is consuming/ has received drugs,
- •which have interaction with Acyclovir, during last
- •15. Chronic alcoholics.
- •16. Drug abusers.
- •17. Participation in any other clinical trial during
- •last 30 days.
Investigators
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