ID

42598

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Significant Medical/ Surgical History And Physical Examination and the Prior Medication form. It has to be filled in for screening.

Keywords

Versions (4)
  1. 9/1/17 9/1/17 -
  2. 6/18/19 6/18/19 -
  3. 6/18/19 6/18/19 -
  4. 9/17/21 9/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

English

Significant Medical/ Surgical History And Physical Examination, Prior Medication

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Description

Volunteer panel number

Data type

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Significant Medical/ Surgical History And Physical Examination
Description

Significant Medical/ Surgical History And Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
Description

If you tick Yes, fill in the follwoing items for each diagnosis. Only in the absence of a diagnosis, record the signs and symptoms on separate lines.

Data type

text

Alias
UMLS CUI [1]
C1699700
UMLS CUI [2]
C0543467
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Year of first diagnosis
Description

Month Year

Data type

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Medical condition
Description

Medical condition

Data type

text

Prior Medication
Description

Prior Medication

Alias
UMLS CUI-1
C2826257
Has the subject taken any medication within 2 weeks prior to the study?
Description

If you tick ‘Yes’, please record each medication in the following items.

Data type

text

Alias
UMLS CUI [1]
C2826257
Drug Name
Description

(Trade name preferred)

Data type

text

Alias
UMLS CUI [1]
C2360065
Single dose
Description

(eg 500 mg)

Data type

text

Alias
UMLS CUI [1]
C1960417
Frequency of this dose
Description

(eg BID, PRN)

Data type

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Description

Other routes may be entered onto the form when appropriate, and will be coded prior to data entry.

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication of medication
Description

Indication on Prior Medication page must correlate utilizing the same terminology. Indication on Concomitant page must be recorded on the Adverse Events Page and expressed utilizing the same terminology.

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Duration of therapy
Description

(e.g. 6 years)

Data type

text

Alias
UMLS CUI [1]
C0444921
End date of therapy/medication
Description

day month year. If therapy/medication is continuing tick the follwing item.

Data type

date

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0806020
Continuing at end of study?
Description

If a medication was marked continuing at the initial visit (on the Prior and Concomitant Medication Page), but has since had a dosage change or has been stopped, it must be recorded on this form as a change with the start and end date.

Data type

text

Alias
UMLS CUI [1]
C1553904
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Similar models

Significant Medical/ Surgical History And Physical Examination, Prior Medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Volunteer panel number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Significant Medical/ Surgical History And Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
text
C1699700 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
medical condition; surgery
Code List
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
CL Item
No (N)
CL Item
Yes (Y)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of diagnosis
Item
Year of first diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Medical condition
text
medical condition
Code List
Medical condition
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Item
Has the subject taken any medication within 2 weeks prior to the study?
text
C2826257 (UMLS CUI [1])
Prior Medication
Code List
Has the subject taken any medication within 2 weeks prior to the study?
CL Item
No (N)
CL Item
Yes (Y)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Single dose
Item
Single dose
text
C1960417 (UMLS CUI [1])
Medication frequency
Item
Frequency of this dose
text
C3476109 (UMLS CUI [1])
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication Route
Code List
Medication Route
CL Item
intra-articular (IA)
CL Item
intra-arterial (IAR)
CL Item
intra-dermal (ID)
CL Item
inhalation (IH)
CL Item
intra-muscular (IM)
CL Item
intra-thecal (IT)
CL Item
intra-venous (IV)
CL Item
nasal (NA)
CL Item
oral (PO)
CL Item
rectal (PR)
CL Item
subcutaneous (SC)
CL Item
sublingual (SL)
CL Item
transdermal (TD)
CL Item
topical (TO)
CL Item
vaginal (VA)
Indication of medication
Item
Indication of medication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Duration of therapy
Item
Duration of therapy
text
C0444921 (UMLS CUI [1])
End date of therapy/medication
Item
End date of therapy/medication
date
C0087111 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item
Continuing at end of study?
text
C1553904 (UMLS CUI [1])
Continuing therapy
Code List
Continuing at end of study?
CL Item
No (N)
CL Item
Yes (Y)
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