| CTRI Number |
CTRI/2015/05/005765 [Registered on: 11/05/2015] Trial Registered Prospectively |
| Last Modified On: |
09/05/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of efficacy and safety of famciclovir and valacyclovir in patients with Herpes zoster. |
|
Scientific Title of Study
|
Comparison of efficacy, cost effectiveness and safety of famciclovir and valacyclovir in Herpes zoster – a randomized controlled double blind parallel arm study. |
| Trial Acronym |
FaVer study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sandhiya |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Clinical Pharmacology
JIPMER
Puducherry
Pondicherry PONDICHERRY 605006. India |
| Phone |
9443492922 |
| Fax |
|
| Email |
sandhiyaselvarajan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S Sandhiya |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Clinical Pharmacology
JIPMER
Puducherry
Pondicherry PONDICHERRY 605006. India |
| Phone |
9443492922 |
| Fax |
|
| Email |
sandhiyaselvarajan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S Sandhiya |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Clinical Pharmacology
JIPMER
Puducherry
Pondicherry PONDICHERRY 605006. India |
| Phone |
9443492922 |
| Fax |
|
| Email |
sandhiyaselvarajan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education Research |
| Address |
Pondicherry
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Sandhiya |
Clinical Pharmacology, JIPMER |
Clinical Research lab, Department of Clinical Pharmacology III floor, Institute block, JIPMER, Dhanvantrinagar, Pondicherry Pondicherry PONDICHERRY |
9443492922
sandhiyaselvarajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (Human studies) JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Herpes zoster, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Famciclovir |
500 mg 3 times daily
for 7 days orally |
| Comparator Agent |
valacyclovir |
1000 mg 3 times daily for 7 days orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients attending Dermatology OPD, JIPMER diagnosed with uncomplicated herpes zoster presenting within 72 hrs of onset of rash will be recruited for the study based on eligibility criteria. |
|
| ExclusionCriteria |
| Details |
Patients with complications of Herpes zoster, including ocular involvement, severe disseminated infections, motor neuropathies, encephalitis or cerebrovascular complications.
Pregnant women or lactating mothers
Patients with concurrent malignancy receiving chemotherapy
Patients with autoimmune diseases and or on immunosuppressants
HIV sero-positive
Renal impairment
Hepatic impairment
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain using visual analogue scale score |
Day 0 and day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time taken for the full crusting of the lesions |
Day 0 and day 8 |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="5" Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Written informed consent will be obtained from all the study participants. Patients who satisfy the eligibility criteria will be enrolled in the study and their pain will be assessed using 10 point (100 mm) visual analog scale (VAS). Following this they will be randomized in the ratio of 1:1 to receive either famciclovir 500mg 3 times daily or valacyclovir 1000mg 3 times daily for a period of 7 days. The drugs will be given in similar looking capsules to blind both participant and the investigator. Participants will be given adherence sheet as well as pain rating sheet to be filled for 7 days and to be returned during 8th day follow up visit. They will be evaluated for pain using VAS and crusting of the cutaneous lesions on day 8 by the blinded observer. The intake of analgesics if any during the study period will be recorded. Following this they will be given a sheet to note down the day of complete healing of lesions. The lesions are defined as fully crusted when all the papules and vesicles in the affected dermatome had resolved and crusts had appeared. If all cutaneous lesions do not crust by 8th day, the patients will be continued on the same drug for another 3 days and will be followed up on 11th day to look for complete crusting of lesions. The participants will be followed over telephone at the end of four weeks and 12 weeks to find out the time taken for healing of cutaneous lesions as well as complete disappearance of pain. Healing is defined as the first time in which a patient had no papules, vesicles / crusts and after which did not develop them at any later visit. |