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.

Phase 3

• Conditions: 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

This is a prospective, randomized, open label, active controlled, parallel group study to investigate efficacy and safety of Acyclovir 1200 mg SR TDS for 7 days compared to Acyclovir 800 mg IR five times a day for 7 days in 100 immunocompetent patients with uncomplicated herpes zoster that will be conducted in 9 different centres across India. The Primary outcome measure will be proportion of patients who reached healing of 100% lesions on day 8, 15, 22 and 29 after initiation the treatment. Secondary outcomes will be proportion of patients showing 100% loss of pain, reduction in severity of the zoster associated acute pain and proportion of patients showing no formation of new lesions on day 4, 8, 15, 22 and 29 after initiation of the treatment.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Written informed consent from the subject.2. Age above 18 years inclusive.3. Diagnosis of herpes zoster clinically verified bya physician.4. Presenting within 72 hrs of onset of a localizedherpes zoster rash.

Exclusion Criteria

• Subjects with any condition which in the opinionof the investigator makes the subject unsuitable forinclusion.2. Complication of herpes zoster: ocular and visceralinvolvement, motor neuropathies, encephalitis,cerebrovascular complications, Severedisseminated infection: (more than 20 lesionsoutside the primary affected dermatome).3.
• Subjects receiving chronic steroid therapy,immunosuppressive therapy, chemotherapy formalignancy.4. HIV positive individual.5. Subjects with autoimmune disorder.6. SGOT and SGPT >/= 2 times the upper limit ofnormal.7. Serum creatinine >/= 2 times the upper limit ofnormal.8. Subject is a female who is pregnant or willing toget pregnant, not ready to use contraceptivemeasures 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 antiviraldrugs 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 last14 days.15.
• Chronic alcoholics.16.
• Drug abusers.17.
• Participation in any other clinical trial duringlast 30 days.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who reached healing of 100% lesions	Day 8, 15, 22 and 29 after initiation the treatment

Secondary Outcome Measures

Name	Time	Method
Reduction in severity of the zoster associated acutepain	Day 4, 8, 15, 22 and 29 after initiation ofthe treatment
Proportion of patients showing no formation of new lesions	Day 4, 8, 15, 22 and 29 afterinitiation of the treatment
Proportion of patients showing 100% loss of pain	Day 4, 8, 15, 22 and 29 after initiation of the treatment

Trial Locations

Locations (9)

B. J. Medical College Civil Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

B. J. Medical College, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Deenanath Mangeshkar Hospital & Research Center, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Grant Medical College and Sir J. J. Hospital, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

K. J. Somaiya Hospital and Research, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

K.E.M. Hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Medical College, Vadodara; 🇮🇳 Vadodara, GUJARAT, India

N. H. L. Medical College & VS Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Shanti Clinic, Navi Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

B. J. Medical College Civil Hospital, Ahmedabad

🇮🇳Ahmadabad, GUJARAT, India

Dr. Bela Shah

Principal investigator

07922683721

shah.drbela@gmail.com