Clinical Trial Details (PDF Generation Date :- Sat, 23 Feb 2019 02:27:19 GMT) CTRI Number CTRI/2009/091/000044 [Registered on: 17/02/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Randomized, Parallel Group, Active Controlled Trial 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. 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. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Dr. Yashwant Tawade K. E. M. Hospital Rasta Peth 411 011 Phone (020)66037339 Fax yeshtwde@vsnl.net Details Contact Person (Scientific Query) Dr. Vivek Bhosale Manager Medical Phone (022)26780652 Fax (022)26786393 142-148, S.V. Road, Jogeshwari(W) 400102 drvivek@fdcindia.com Details Contact Person (Public Query) Dr. Vivek Bhosale Phone (022)26780652 142-148, S.V. Road, Jogeshwari(W) 400102 page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Fax (022)26786393 drvivek@fdcindia.com Source of Monetary or Material Support > FDC Limited,142-148, S.V.Road, Jogeshwari (W), - 400102, Maharashtra, Primary Sponsor Details FDC Limited,142-148, S.V.Road, Jogeshwari (W), - 400102, Maharashtra, Type of Sponsor List of Countries of Principal Investigator Dr. Bela Shah Dr. Sunil Tolat Dr. Vinay Kulkarni Dr. Mahendra Kura Dr. Pravin Banodkar of Site Site Phone/Fax/ B. J. Medical College Civil Hospital, B. J. Medical College, Deenanath Mangeshkar Hospital & Research Center, Grant Medical College and Sir J. J. Hospital, K. J. Somaiya Hospital and Research,,-380016 Ahmadabad Jai Prakash Narayan Path,Station Road-411001 Erandwane,-411004 Opd No. 42/Ward No. 43,Byculla-400008 Sion,-400022 Dr. Yashwant Tawade K.E.M. Hospital, Rasta Peth,-411001 Dr. Yogesh Marfatia Dr. Ranjan Raval Dr. Satish Udare Medical College, N. H. L. Medical College & VS Hospital, Shanti Clinic, Navi,-390001 Elisbridge,-380006 Ahmadabad 26A, Shanti Centre,Sector 17, Vashi-400703 07922683721 shah.drbela@gmail.co m 02026128000 suniltolat@hotmail.com 02040151901 prayashealth@vsnl.net 02223735555 drkura@gmail.com 9867955944 pravin_banodkar@hotm ail.com 02066037339 yeshtwade@vsnl.com 02652424848 ym11256@yahoo.com 0792657721 ranjanmb@yahoo.com 02227894764 of Committee Approval Status Date of Approval Is Independent Ethics Committee? Drushti Independent page 2 / 5
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Ethics committee, B.J.Medical College & Sassoon General Hospital, K.E.M. Hospital Research Centre, Medical College, Ethics Committee/IRB of K.J.Somaiya Medical College & Hospital, Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre, Intitutional Ethics Committee, Grant Medical college & Sir J.J.Group of Hospitals, The B.J.Medical College & Civil Hospital, The Institutional Ethics Committee, Sheth Vadilal Sarabhai General Hospital, Status Approved/Obtained Health Type Submittted/Under Review Not Available Date Condition Uncomplicated Herpes Zoster Type Details Intervention Acyclovir 1200 Mg Sustained Release TDS for 7 days Comparator Agent Acyclovir 800 Mg- Immediate Release 5 times a day for 7 days Age From Age To Gender Details Details 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 inclusion. 2. Complication of herpes zoster: ocular and visceral involvement, motor neuropathies, page 3 / 5
Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization An Open list of random numbers Open Label 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. Primary Outcome Outcome Timepoints Proportion of patients who reached healing of 100% lesions Day 8, 15, 22 and 29 after initiation the Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Reduction in severity of the zoster associated acute pain Proportion of patients showing no formation of new lesions Day 4, 8, 15, 22 and 29 after initiation of the Day 4, 8, 15, 22 and 29 after initiation of the Proportion of patients showing 100% loss of pain Day 4, 8, 15, 22 and 29 after initiation of the Total Sample Size=0 Sample Size from = 23/12/2008 Years= Months=0 Days=0 Completed 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. 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. 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 page 4 / 5
Powered by TCPDF (www.tcpdf.org) new lesions on day 4, 8, 15, 22 and 29 after initiation of the. page 5 / 5