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.
- Registration Number
- CTRI/2009/091/000044
- Lead Sponsor
- FDC Limited,142-148, S.V.Road, Jogeshwari (W), Mumbai - 400102, Maharashtra, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
1. Subjects with any condition which in the opinion
of the investigator makes the subject unsuitable for
inclusion.
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
normal.
7. Serum creatinine >/= 2 times the upper limit of
normal.
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
14 days.
15. Chronic alcoholics.
16. Drug abusers.
17. Participation in any other clinical trial during
last 30 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who reached healing of 100% lesionsTimepoint: Day 8, 15, 22 and 29 after initiation the treatment
- Secondary Outcome Measures
Name Time Method Proportion of patients showing 100% loss of painTimepoint: Day 4, 8, 15, 22 and 29 after initiation of the treatment;Proportion of patients showing no formation of new lesionsTimepoint: Day 4, 8, 15, 22 and 29 after<br>initiation of the treatment;Reduction in severity of the zoster associated acute<br>painTimepoint: Day 4, 8, 15, 22 and 29 after initiation of<br>the treatment