ID

36707

Description

The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands; ODM derived from: https://clinicaltrials.gov/show/NCT02485145

Link

https://clinicaltrials.gov/show/NCT02485145

Keywords

Versions (1)
  1. 6/3/19 6/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Hands NCT02485145

English

Eligibility Osteoarthritis of the Hands NCT02485145

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
oa in at least one hand as defined by acr criteria (nodal enlargement in two or more of 10 defined joints, cmc-1, mcp=1, pips and dips).
Description

Osteoarthritis of the hand ACR Improvement Criteria | Joint enlargement | Carpometacarpal joint | Metacarpophalangeal joint | Proximal interphalangeal joint | Distal interphalangeal joint

Data type

boolean

Alias
UMLS CUI [1,1]
C0263746
UMLS CUI [1,2]
C3273747
UMLS CUI [2]
C4478413
UMLS CUI [3]
C1321524
UMLS CUI [4]
C0025525
UMLS CUI [5]
C0932508
UMLS CUI [6]
C0932510
hand pain duration greater than one year.
Description

Hand pain Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0239833
UMLS CUI [1,2]
C0449238
history of nsaid use for hand pain on at least one occasion during the last year.
Description

NSAID Hand pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0239833
age 40 to 79 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ability to understand the english language and to comprehend written material at the 5th grade level.
Description

Comprehension English Language Grade Level

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0870612
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of psoriasis
Description

Psoriasis

Data type

boolean

Alias
UMLS CUI [1]
C0033860
other painful rheumatic disease, measured by a blood draw that will test for rf factor and esr.
Description

Rheumatic disorder painful | Blood draw | Rheumatoid Factor Measurement | Erythrocyte sedimentation rate measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C3495832
UMLS CUI [1,2]
C0030193
UMLS CUI [2]
C0005834
UMLS CUI [3]
C0201660
UMLS CUI [4]
C1176468
rheumatoid arthritis, as measured by hand x-rays.
Description

Rheumatoid Arthritis X-ray of hand

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0438993
any diagnosis of fibromyalgia or neurovascular disease.
Description

Fibromyalgia | Neurovascular Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0016053
UMLS CUI [2]
C3898144
presence of raynaud's disease.
Description

Raynaud Disease

Data type

boolean

Alias
UMLS CUI [1]
C0034734
-presence of raynaud's disease.
Description

Presence of Raynaud Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0150312
UMLS CUI [1,2]
C0034734
presence of any peripheral neuropathy.
Description

Peripheral Neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
presence of cervical radiculopathy.
Description

Radiculopathy, Cervical

Data type

boolean

Alias
UMLS CUI [1]
C0742186
pregnancy in females (pregnancy test will be administered at intake to females of reproductive capability and their method of birth control recorded.)
Description

Pregnancy | Childbearing Potential Pregnancy Test | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
persons under age 40. insufficient data are available in adults to judge potential risk in children.
Description

Age | Adult | Availability of Data Insufficient

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0001675
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C1511726
UMLS CUI [3,3]
C0231180
those who are not capable of providing informed consent.
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
known allergy to analgesic drugs and the drugs used in this study.
Description

Allergy to analgesic agent | Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0260490
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
those who do not comprehend english. as this is a short-term pilot study, the potential benefits to the participants is currently unknown. based upon this knowledge, we believe we are exempt from the requirement to translate the informed consent form into spanish.
Description

Lacking Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0233733
UMLS CUI [1,3]
C0376245
those with renal and/or gastrointestinal impairments, i.e. with a creatinine level of 2 and gfs level 4.
Description

Renal Insufficiency | Impairment gastrointestinal | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2,1]
C0221099
UMLS CUI [2,2]
C0521362
UMLS CUI [3]
C0201976
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Similar models

Eligibility Osteoarthritis of the Hands NCT02485145

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Osteoarthritis of the hand ACR Improvement Criteria | Joint enlargement | Carpometacarpal joint | Metacarpophalangeal joint | Proximal interphalangeal joint | Distal interphalangeal joint
Item
oa in at least one hand as defined by acr criteria (nodal enlargement in two or more of 10 defined joints, cmc-1, mcp=1, pips and dips).
boolean
C0263746 (UMLS CUI [1,1])
C3273747 (UMLS CUI [1,2])
C4478413 (UMLS CUI [2])
C1321524 (UMLS CUI [3])
C0025525 (UMLS CUI [4])
C0932508 (UMLS CUI [5])
C0932510 (UMLS CUI [6])
Hand pain Duration
Item
hand pain duration greater than one year.
boolean
C0239833 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
NSAID Hand pain
Item
history of nsaid use for hand pain on at least one occasion during the last year.
boolean
C0003211 (UMLS CUI [1,1])
C0239833 (UMLS CUI [1,2])
Age
Item
age 40 to 79 years.
boolean
C0001779 (UMLS CUI [1])
Comprehension English Language Grade Level
Item
ability to understand the english language and to comprehend written material at the 5th grade level.
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0870612 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Psoriasis
Item
history of psoriasis
boolean
C0033860 (UMLS CUI [1])
Rheumatic disorder painful | Blood draw | Rheumatoid Factor Measurement | Erythrocyte sedimentation rate measurement
Item
other painful rheumatic disease, measured by a blood draw that will test for rf factor and esr.
boolean
C3495832 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2])
C0201660 (UMLS CUI [3])
C1176468 (UMLS CUI [4])
Rheumatoid Arthritis X-ray of hand
Item
rheumatoid arthritis, as measured by hand x-rays.
boolean
C0003873 (UMLS CUI [1,1])
C0438993 (UMLS CUI [1,2])
Fibromyalgia | Neurovascular Disorder
Item
any diagnosis of fibromyalgia or neurovascular disease.
boolean
C0016053 (UMLS CUI [1])
C3898144 (UMLS CUI [2])
Raynaud Disease
Item
presence of raynaud's disease.
boolean
C0034734 (UMLS CUI [1])
Presence of Raynaud Disease
Item
-presence of raynaud's disease.
boolean
C0150312 (UMLS CUI [1,1])
C0034734 (UMLS CUI [1,2])
Peripheral Neuropathy
Item
presence of any peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1])
Radiculopathy, Cervical
Item
presence of cervical radiculopathy.
boolean
C0742186 (UMLS CUI [1])
Pregnancy | Childbearing Potential Pregnancy Test | Childbearing Potential Contraceptive methods
Item
pregnancy in females (pregnancy test will be administered at intake to females of reproductive capability and their method of birth control recorded.)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Age | Adult | Availability of Data Insufficient
Item
persons under age 40. insufficient data are available in adults to judge potential risk in children.
boolean
C0001779 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C0470187 (UMLS CUI [3,1])
C1511726 (UMLS CUI [3,2])
C0231180 (UMLS CUI [3,3])
Informed Consent Unable
Item
those who are not capable of providing informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Allergy to analgesic agent | Hypersensitivity Investigational New Drugs
Item
known allergy to analgesic drugs and the drugs used in this study.
boolean
C0260490 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Lacking Comprehension English Language
Item
those who do not comprehend english. as this is a short-term pilot study, the potential benefits to the participants is currently unknown. based upon this knowledge, we believe we are exempt from the requirement to translate the informed consent form into spanish.
boolean
C0332268 (UMLS CUI [1,1])
C0233733 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Renal Insufficiency | Impairment gastrointestinal | Creatinine measurement, serum
Item
those with renal and/or gastrointestinal impairments, i.e. with a creatinine level of 2 and gfs level 4.
boolean
C1565489 (UMLS CUI [1])
C0221099 (UMLS CUI [2,1])
C0521362 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
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