ID

30490

Description

https://clinicaltrials.gov/ct2/show/NCT00344006 Study ID : CDA 714703/005 Clinical Study ID :714703/005 Study Title :A multi-centre, randomised, double-blind, double dummy study comparing the efficacy and safety of chlorproguanil-dapsone-artesunate versus artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in children and adolescents in Africa. Patient Level Data : Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier : NCT00344006 Sponsor : GlaxoSmithKline Collaborators : N/A Phase phase :3 Study Recruitment Status : Completed Generic Name : artesunate/chlorproguanil/dapsone Trade Name : LAPDAP + ARTESUNATE Study Indication : Malaria, Falciparum

Link

https://clinicaltrials.gov/ct2/show/NCT00344006

Keywords

Versions (1)
  1. 6/8/18 6/8/18 - Halim Ugurlu
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

June 8, 2018

DOI

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License

Creative Commons BY-NC 3.0
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NCT00344006-Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria

English

Case Report From, Module Number 1.2 (Visits included in this module: Day 0)

1 forms  
Administrative Information
Description

Administrative Information

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Malaria Signs and Symptoms
Description

Malaria Signs and Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C0024530
Chills and rigors
Description

Chills and rigors

Data type

text

Alias
UMLS CUI [1]
C0036973
Headache
Description

Headache

Data type

text

Alias
UMLS CUI [1]
C0018681
Dizziness
Description

Dizziness

Data type

text

Alias
UMLS CUI [1]
C0012833
Abdominal Pain
Description

Abdominal Pain

Data type

text

Alias
UMLS CUI [1]
C0000737
Anorexia
Description

Anorexia

Data type

text

Alias
UMLS CUI [1]
C0003123
Nausea
Description

Nausea

Data type

text

Alias
UMLS CUI [1]
C0027497
Vomiting
Description

Vomiting

Data type

text

Alias
UMLS CUI [1]
C0042963
Diarrhoea
Description

Diarrhoea

Data type

text

Alias
UMLS CUI [1]
C0011991
Pruritis/itching
Description

Pruritis/itching

Data type

text

Alias
UMLS CUI [1]
C0033774
Coughing
Description

Coughing

Data type

text

Alias
UMLS CUI [1]
C0010200
Other, specify
Description

Other, specify

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
Vital Signs-8 Hours Post First Dose
Description

Vital Signs-8 Hours Post First Dose

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Temperature
Description

Temperature

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0039476
C
Location of Temperature
Description

Location of Temperature

Data type

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
Vital Signs-16 Hours Post First Dose
Description

Vital Signs-16 Hours Post First Dose

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Temperature
Description

Temperature

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0039476
C
Location of Temperature
Description

Location of Temperature

Data type

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 8 Hours Post First Dose
Description

MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 8 Hours Post First Dose

Alias
UMLS CUI-1
C3661511
UMLS CUI-2
C0024530
UMLS CUI-3
C0086960
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
P. falciparum Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032150
UMLS CUI [1,2]
C1254595
/UL
P. vivax Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032154
UMLS CUI [1,2]
C1254595
/UL
P. ovale Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0320744
UMLS CUI [1,2]
C1254595
/UL
P. malariae Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032153
UMLS CUI [1,2]
C1254595
/UL
Unknown Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0439673
UMLS CUI [1,2]
C1254595
/UL
MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 16 Hours Post First Dose
Description

MALARIA PARASITOLOGY SCHEDULE - MULTIPLE ASSESSMENTS - SINGLE VISIT - 16 Hours Post First Dose

Alias
UMLS CUI-1
C3661511
UMLS CUI-2
C0024530
UMLS CUI-3
C0086960
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
P. falciparum Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032150
UMLS CUI [1,2]
C1254595
/UL
P. vivax Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032154
UMLS CUI [1,2]
C1254595
/UL
P. ovale Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0320744
UMLS CUI [1,2]
C1254595
/UL
P. malariae Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0032153
UMLS CUI [1,2]
C1254595
/UL
Unknown Results
Description

POS=Positive NEG=Negative

Data type

text

Measurement units
  • /UL
Alias
UMLS CUI [1,1]
C0439673
UMLS CUI [1,2]
C1254595
/UL
INVESTIGATIONAL PRODUCT CONTAINER NUMBER
Description

INVESTIGATIONAL PRODUCT CONTAINER NUMBER

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Chlorproguanil-Dapsone-Artesunate or Placebo
Description

INVESTIGATIONAL PRODUCT CONTAINER NUMBER

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Artemether Lumefantrine or Placebo
Description

please write "Not applicable" if not applicable

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
INVESTIGATIONAL PRODUCT: CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO
Description

INVESTIGATIONAL PRODUCT: CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0055470
UMLS CUI-3
C0010980
UMLS CUI-4
C0052432
UMLS CUI-6
C0032042
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Dose (tab)
Description

Dose (tab)

Data type

float

Alias
UMLS CUI [1]
C3174092
Size of tablets
Description

Size of tablets

Data type

text

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Was dose vomited within 30 minutes?
Description

Was dose vomited within 30 minutes?

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C3174092
Did the subject receive breast milk or food no less than 30 minutes prior to dosing?
Description

receive breast milk or food

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0678766
Were tablets crushed?
Description

Were tablets crushed?

Data type

boolean

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0185060
INVESTIGATIONAL PRODUCT: IP REDOSE-CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO
Description

INVESTIGATIONAL PRODUCT: IP REDOSE-CHLORPROGUANIL-DAPSONE-ARTESUNATE OR PLACEBO

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0055470
UMLS CUI-3
C0010980
UMLS CUI-4
C0052432
UMLS CUI-5
C0032042
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Dose (tab)
Description

Dose (tab)

Data type

float

Alias
UMLS CUI [1]
C3174092
Size of tablets
Description

Size of tablets

Data type

text

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Was dose vomited within 30 minutes?
Description

Was dose vomited within 30 minutes?

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C3174092
Did the subject receive breast milk or food n