Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006131
Status:
COMPLETED
Last Update Posted:
2007-05-24
First Post:
2000-08-03
Brief Title:
Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Compare the efficacy and safety of two doses of oral valacyclovir in immunocompromised patients with uncomplicated herpes zoster
II Compare quality of life pain and medical resource utilization in patients treated with these 2 regimens
I Compare the efficacy and safety of two doses of oral valacyclovir in immunocompromised patients with uncomplicated herpes zoster
II Compare quality of life pain and medical resource utilization in patients treated with these 2 regimens
Detailed Description:
PROTOCOL OUTLINE
This is a randomized double blind study
Patients are randomized to one of two treatment arms
Arm I Patients receive standard dose oral valacyclovir three times a day on Days 1-7
Arm II Patients receive higher dose oral valacyclovir three times a day on Days 1-7
Both arms Patients begin treatment within 72 hours after onset of zoster rash
Quality of life is assessed on Days 1 14 and 28 during study and then every 4 weeks through Week 24 Pain is assessed on Days 1-28 during study and then weekly through Week 24 Medical resource utilization is assessed on Days 1 8 14 and 18 during study and then every 4 weeks through Week 24
Patients are followed every 4 weeks through Week 24
This is a randomized double blind study
Patients are randomized to one of two treatment arms
Arm I Patients receive standard dose oral valacyclovir three times a day on Days 1-7
Arm II Patients receive higher dose oral valacyclovir three times a day on Days 1-7
Both arms Patients begin treatment within 72 hours after onset of zoster rash
Quality of life is assessed on Days 1 14 and 28 during study and then every 4 weeks through Week 24 Pain is assessed on Days 1-28 during study and then weekly through Week 24 Medical resource utilization is assessed on Days 1 8 14 and 18 during study and then every 4 weeks through Week 24
Patients are followed every 4 weeks through Week 24
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTMB-GCRC-D085 | None | None | None |
| UTMB-97-120 | None | None | None |
| GW-R-24 | None | None | None |