| CTRI Number |
CTRI/2009/091/000044 [Registered on: 17/02/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
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. |
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Scientific Title of Study
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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. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Yashwant Tawade |
| Designation |
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| Affiliation |
|
| Address |
K. E. M. Hospital
Rasta Peth
Pune
MAHARASHTRA
411 011
India |
| Phone |
(020)66037339 |
| Fax |
|
| Email |
yeshtwde@vsnl.net |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Vivek Bhosale |
| Designation |
|
| Affiliation |
Manager Medical |
| Address |
142-148, S.V. Road, Jogeshwari(W)
Mumbai
MAHARASHTRA
400102
India |
| Phone |
(022)26780652 |
| Fax |
(022)26786393 |
| Email |
drvivek@fdcindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vivek Bhosale |
| Designation |
|
| Affiliation |
|
| Address |
142-148, S.V. Road, Jogeshwari(W)
Mumbai
MAHARASHTRA
400102
India |
| Phone |
(022)26780652 |
| Fax |
(022)26786393 |
| Email |
drvivek@fdcindia.com |
|
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Source of Monetary or Material Support
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| FDC Limited,142-148, S.V.Road, Jogeshwari (W), Mumbai - 400102, Maharashtra, India |
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Primary Sponsor
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| Name |
FDC Limited,142-148, S.V.Road, Jogeshwari (W), Mumbai - 400102, Maharashtra, India |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Bela Shah |
B. J. Medical College Civil Hospital, Ahmedabad |
,-380016
Ahmadabad
GUJARAT |
07922683721
shah.drbela@gmail.com |
| Dr. Sunil Tolat |
B. J. Medical College, Pune |
Jai Prakash Narayan Path,Station Road-411001
Pune
MAHARASHTRA |
02026128000
suniltolat@hotmail.com |
| Dr. Vinay Kulkarni |
Deenanath Mangeshkar Hospital & Research Center, Pune |
Erandwane,-411004
Pune
MAHARASHTRA |
02040151901
prayashealth@vsnl.net |
| Dr. Mahendra Kura |
Grant Medical College and Sir J. J. Hospital, Mumbai |
Opd No. 42/Ward No. 43,Byculla-400008
Mumbai
MAHARASHTRA |
02223735555
drkura@gmail.com |
| Dr. Pravin Banodkar |
K. J. Somaiya Hospital and Research, Mumbai |
Sion,-400022
Mumbai
MAHARASHTRA |
9867955944
pravin_banodkar@hotmail.com |
| Dr. Yashwant Tawade |
K.E.M. Hospital, Pune |
Rasta Peth,-411001
Pune
MAHARASHTRA |
02066037339
yeshtwade@vsnl.com |
| Dr. Yogesh Marfatia |
Medical College, Vadodara |
,-390001
Vadodara
GUJARAT |
02652424848
ym11256@yahoo.com |
| Dr. Ranjan Raval |
N. H. L. Medical College & VS Hospital, Ahmedabad |
Elisbridge,-380006
Ahmadabad
GUJARAT |
0792657721
ranjanmb@yahoo.com |
| Dr. Satish Udare |
Shanti Clinic, Navi Mumbai |
26A, Shanti Centre,Sector 17, Vashi-400703
Mumbai
MAHARASHTRA |
02227894764
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Details of Ethics Committee
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| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Drushti Independent Ethics Committee, Mumbai |
Approved |
| Ethics committee, B.J.Medical College & Sassoon General Hospital, Pune |
Approved |
| Ethics Committee, K.E.M. Hospital Research Centre, Pune |
Approved |
| Ethics Committee, Medical College, Vadodara |
Submittted/Under Review |
| Ethics Committee/IRB of K.J.Somaiya Medical College & Hospital, Mumbai |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre, Pune |
Approved |
| Intitutional Ethics Committee, Grant Medical college & Sir J.J.Group of Hospitals, Mumbai |
Approved |
| The Ethics Committee, B.J.Medical College & Civil Hospital, Ahmedabad |
Approved |
| The Institutional Ethics Committee, Sheth Vadilal Sarabhai General Hospital, Ahmedabad |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Uncomplicated Herpes Zoster, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
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 |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Proportion of patients who reached healing of 100% lesions |
Day 8, 15, 22 and 29 after initiation the treatment |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of the zoster associated acute
pain |
Day 4, 8, 15, 22 and 29 after initiation of
the treatment |
| Proportion of patients showing no formation of new lesions |
Day 4, 8, 15, 22 and 29 after
initiation of the treatment |
| Proportion of patients showing 100% loss of pain |
Day 4, 8, 15, 22 and 29 after initiation of the treatment |
|
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Target Sample Size
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Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/12/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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. |