ID

13360

Description

A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00524160

Link

https://clinicaltrials.gov/show/NCT00524160

Keywords

Versions (1)
  1. 2/9/16 2/9/16 -
Uploaded on

February 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Arthritis NCT00524160

English

Eligibility Arthritis NCT00524160

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Arthritis NCT00524160
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patients must meet the american college of rheumatology criteria for rheumatoid arthritis (ra) or osteoarthritis (oa) of the hip or knee and have moderate or severe pain that is not adequately controlled by other medications (paracetamol (acetaminophen), nsaids, cox-2 inhibitors, weak opioids)
Description

rheuma diagnosis and comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0029408
UMLS CUI [3]
C0409959
UMLS CUI [4]
C0029410
UMLS CUI [5,1]
C0747149
UMLS CUI [5,2]
C1299393
OA patients must be in need of and waiting for hip or knee replacement
Description

need for hip or knee replacement

Data type

boolean

Alias
UMLS CUI [1,1]
C0392806
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0408406
UMLS CUI [2,2]
C0686904
RA patients using disease modifying antirheumatic drugs (dmards) must have been on stable dose of medication for >=3 months.
Description

stable dose of medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0178602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patients who have received regular treatment with strong opioids during the month prior to study
Description

regular treatment with strong opioids

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0242402
UMLS CUI [1,3]
C0442821
Another continuous pain that stands out compared to RA or OA pain
Description

another continuous pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1524062
Skin disease or known allergy or hypersensitivity to fentanyl or to the adhesives
Description

skin disease or hypersensitivity to fentanyl

Data type

boolean

Alias
UMLS CUI [1]
C0037274
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015846
History of liver disease
Description

liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
New physical therapy or change in that therapy within one month of study
Description

new or other therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0443172
Pregnant or nursing females, or those without adequate contraception.
Description

pregnancy lactation and contraceptive use

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1999124
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Similar models

Eligibility Arthritis NCT00524160

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Arthritis NCT00524160
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
rheuma diagnosis and comorbidities
Item
Patients must meet the american college of rheumatology criteria for rheumatoid arthritis (ra) or osteoarthritis (oa) of the hip or knee and have moderate or severe pain that is not adequately controlled by other medications (paracetamol (acetaminophen), nsaids, cox-2 inhibitors, weak opioids)
boolean
C0003873 (UMLS CUI [1])
C0029408 (UMLS CUI [2])
C0409959 (UMLS CUI [3])
C0029410 (UMLS CUI [4])
C0747149 (UMLS CUI [5,1])
C1299393 (UMLS CUI [5,2])
need for hip or knee replacement
Item
OA patients must be in need of and waiting for hip or knee replacement
boolean
C0392806 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0408406 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
stable dose of medication
Item
RA patients using disease modifying antirheumatic drugs (dmards) must have been on stable dose of medication for >=3 months.
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
regular treatment with strong opioids
Item
Patients who have received regular treatment with strong opioids during the month prior to study
boolean
C0087111 (UMLS CUI [1,1])
C0242402 (UMLS CUI [1,2])
C0442821 (UMLS CUI [1,3])
another continuous pain
Item
Another continuous pain that stands out compared to RA or OA pain
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
skin disease or hypersensitivity to fentanyl
Item
Skin disease or known allergy or hypersensitivity to fentanyl or to the adhesives
boolean
C0037274 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0015846 (UMLS CUI [2,2])
liver disease
Item
History of liver disease
boolean
C0023895 (UMLS CUI [1])
new or other therapy
Item
New physical therapy or change in that therapy within one month of study
boolean
C0087111 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
pregnancy lactation and contraceptive use
Item
Pregnant or nursing females, or those without adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1999124 (UMLS CUI [3])
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