ID

22464

Description

Study ID: 100273 Clinical Study ID: HS2100273 Study Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter 60-Day Study Comparing the Efficacy of Valtrex 1 Gram Once Daily vs. Placebo Once Daily in Reducing Viral Shedding in Immunocompetent Subjects with Recurrent HSV-2 Genital Herpes Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Herpes Genitalis Visit description: Investigational Product

Keywords

Versions (1)
  1. 6/5/17 6/5/17 -
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June 5, 2017

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Creative Commons BY-NC 3.0
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Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Study Investigational Product

English

Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Study Investigational Product

1 forms  
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Description

Investigational Product

Data type

text

Alias
UMLS CUI [1]
C0304229
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Investigational Product Compliance
Description

Investigational Product Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Investigational Product
Description

Investigational Product

Data type

text

Alias
UMLS CUI [1]
C0304229
Date Investigational Product Dispensed
Description

Date Investigational Product Dispensed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C0304229
Number of Tablets/Caplets Dispensed
Description

Number of Tablets Dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0304229
Date Investigational Product Returned
Description

Date Investigational Product Returned

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0304229
Number of Tablets/Caplets Returned
Description

Number of Tablets Returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0304229
Investigational Product Discontinuation
Description

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Description

investigational product stopped

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
If Yes, check the primary reason the investigational product was stopped:
Description

reason the investigational product was stopped

Data type

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0457454
If other reason, please specify
Description

reason the investigational product was stopped

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0457454
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Similar models

Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Study Investigational Product

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Date Investigational Product Dispensed
Item
Date Investigational Product Dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Number of Tablets Dispensed
Item
Number of Tablets/Caplets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Date Investigational Product Returned
Item
Date Investigational Product Returned
date
C0011008 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Number of Tablets Returned
Item
Number of Tablets/Caplets Returned
integer
C2699071 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
investigational product stopped
Code List
Was the investigational product stopped permanently before the end of the scheduled treatment period?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, check the primary reason the investigational product was stopped:
integer
C0392360 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
reason the investigational product was stopped
Code List
If Yes, check the primary reason the investigational product was stopped:
CL Item
Adverse event , Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.  (1)
CL Item
Lost to follow-up  (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study  (4)
CL Item
Other (5)
reason the investigational product was stopped
Item
If other reason, please specify
text
C0392360 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
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