ID

18700

Beskrivning

Civamide in OA of the Knee(s); ODM derived from: https://clinicaltrials.gov/show/NCT00077935

Länk

https://clinicaltrials.gov/show/NCT00077935

Nyckelord

Versioner (1)
  1. 2016-11-16 2016-11-16 -
Uppladdad den

16 november 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT00077935

Engelsk

Eligibility Osteoarthritis, Knee NCT00077935

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject voluntarily agrees to participate in this study and signs an irb-approved informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
subject has participated (and not withdrawn secondary to any adverse event) in the phase 3 osteoarthritis study wl-1001-05-01 and completed end-of-study/final visit preferably < 30 days prior to day 1 of this study (wl-1001-05-04).
Beskrivning

Study Subject Participation Status | Osteoarthritis Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C0008976
subject is between 40 and 76 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
subject is generally in good health.
Beskrivning

General health good

Datatyp

boolean

Alias
UMLS CUI [1]
C1277245
subject is expected to be compliant with study procedures.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
female subjects of child-bearing potential must have a negative urine pregnancy test at day 1.
Beskrivning

Childbearing Potential Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
female subjects of child-bearing potential agree to use an approved form of contraception and must be on the same contraceptive method and dosage schedule during the entire study.
Beskrivning

Childbearing Potential Contraceptive method Singular Unchanged

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205171
UMLS CUI [1,4]
C2346711
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of tendonitis, bursitis, partial or complete joint replacement of knee(s).
Beskrivning

Tendonitis | Bursitis | Arthroplasty, Replacement, Partial Knee | Knee Replacement Arthroplasty

Datatyp

boolean

Alias
UMLS CUI [1]
C0039503
UMLS CUI [2]
C0006444
UMLS CUI [3]
C0864243
UMLS CUI [4]
C0086511
presence of active skin disease, erythema, infection, wound, or irritation near the treatment area of the knee(s).
Beskrivning

Dermatologic disorder Near Treatment Area Knee | Erythema | Communicable Diseases | Injury wounds | Irritation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C1706276
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0205146
UMLS CUI [1,5]
C0022742
UMLS CUI [2]
C0041834
UMLS CUI [3]
C0009450
UMLS CUI [4]
C0043250
UMLS CUI [5]
C1706307
subject has an anticipated need for any surgical or other invasive procedure (e.g., synovial fluid aspiration, arthroscopy, tidal joint irrigation, injectable medications) that will be performed on the knees during the course of the study.
Beskrivning

Operative procedure on knee Patient need for | Invasive procedure Knee Patient need for | Synovial Fluid Aspiration | Arthroscopy | Irrigation of joint | Injectables

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0187769
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C4048276
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0686904
UMLS CUI [3,1]
C0039097
UMLS CUI [3,2]
C0349707
UMLS CUI [4]
C0003904
UMLS CUI [5]
C0408211
UMLS CUI [6]
C0086466
subject has a history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory oa, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease.
Beskrivning

Rheumatoid Arthritis | Fibromyalgia | Connective Tissue Disease | Arthritis, Psoriatic | Erosive osteoarthrosis inflammatory | skeletal hyperostosis idiopathic Diffuse | nervous system disorder Severe | Vascular Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0016053
UMLS CUI [3]
C0009782
UMLS CUI [4]
C0003872
UMLS CUI [5,1]
C0451840
UMLS CUI [5,2]
C0333348
UMLS CUI [6,1]
C1399999
UMLS CUI [6,2]
C0332240
UMLS CUI [6,3]
C0205219
UMLS CUI [7,1]
C0027765
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0042373
UMLS CUI [8,2]
C0205082
subject has active (redness, swelling, fever, etc.) gout or pseudo-gout within 6 months prior to screening.
Beskrivning

Gout | Pseudogout | Redness | Swelling | Fever

Datatyp

boolean

Alias
UMLS CUI [1]
C0018099
UMLS CUI [2]
C0033802
UMLS CUI [3]
C0332575
UMLS CUI [4]
C0038999
UMLS CUI [5]
C0015967
subject has type i or type ii diabetes with peripheral neuropathies.
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Peripheral Neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0031117
subject has had trauma or surgery to the knee(s) within 1 year prior to the enrollment period.
Beskrivning

Knee Injuries | Operative procedure on knee

Datatyp

boolean

Alias
UMLS CUI [1]
C0022744
UMLS CUI [2]
C0187769
subject has an underlying clinical condition, including previous malignancies that in the investigator's judgment, is unstable.
Beskrivning

Condition Clinical Unstable | Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0443343
UMLS CUI [2]
C0006826
subject has known allergy or hypersensitivity to capsicum, civamide, or capsaicin-containing products or any constituent of the cream formulation.
Beskrivning

Hypersensitivity Capsicum extract | Hypersensitivity zucapsaicin | Hypersensitivity Product Capsaicin Containing | Hypersensitivity Capsaicin cream preparation Constituents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1095803
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0763832
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1514468
UMLS CUI [3,3]
C0006931
UMLS CUI [3,4]
C0332256
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0006931
UMLS CUI [4,3]
C0304245
UMLS CUI [4,4]
C0729650
subject has a history of substance abuse within the past 12 months.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
use of certain medications within the given restriction period prior to randomization and during the study.
Beskrivning

Pharmaceutical Preparations Use During Restriction Period

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0443288
UMLS CUI [1,5]
C1948053
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Similar models

Eligibility Osteoarthritis, Knee NCT00077935

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subject voluntarily agrees to participate in this study and signs an irb-approved informed consent.
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status | Osteoarthritis Clinical Trial
Item
subject has participated (and not withdrawn secondary to any adverse event) in the phase 3 osteoarthritis study wl-1001-05-01 and completed end-of-study/final visit preferably < 30 days prior to day 1 of this study (wl-1001-05-04).
boolean
C2348568 (UMLS CUI [1])
C0029408 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Age
Item
subject is between 40 and 76 years of age.
boolean
C0001779 (UMLS CUI [1])
General health good
Item
subject is generally in good health.
boolean
C1277245 (UMLS CUI [1])
Protocol Compliance
Item
subject is expected to be compliant with study procedures.
boolean
C0525058 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative
Item
female subjects of child-bearing potential must have a negative urine pregnancy test at day 1.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Childbearing Potential Contraceptive method Singular Unchanged
Item
female subjects of child-bearing potential agree to use an approved form of contraception and must be on the same contraceptive method and dosage schedule during the entire study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C2346711 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Tendonitis | Bursitis | Arthroplasty, Replacement, Partial Knee | Knee Replacement Arthroplasty
Item
presence of tendonitis, bursitis, partial or complete joint replacement of knee(s).
boolean
C0039503 (UMLS CUI [1])
C0006444 (UMLS CUI [2])
C0864243 (UMLS CUI [3])
C0086511 (UMLS CUI [4])
Dermatologic disorder Near Treatment Area Knee | Erythema | Communicable Diseases | Injury wounds | Irritation
Item
presence of active skin disease, erythema, infection, wound, or irritation near the treatment area of the knee(s).
boolean
C0037274 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205146 (UMLS CUI [1,4])
C0022742 (UMLS CUI [1,5])
C0041834 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C0043250 (UMLS CUI [4])
C1706307 (UMLS CUI [5])
Operative procedure on knee Patient need for | Invasive procedure Knee Patient need for | Synovial Fluid Aspiration | Arthroscopy | Irrigation of joint | Injectables
Item
subject has an anticipated need for any surgical or other invasive procedure (e.g., synovial fluid aspiration, arthroscopy, tidal joint irrigation, injectable medications) that will be performed on the knees during the course of the study.
boolean
C0187769 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C4048276 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0039097 (UMLS CUI [3,1])
C0349707 (UMLS CUI [3,2])
C0003904 (UMLS CUI [4])
C0408211 (UMLS CUI [5])
C0086466 (UMLS CUI [6])
Rheumatoid Arthritis | Fibromyalgia | Connective Tissue Disease | Arthritis, Psoriatic | Erosive osteoarthrosis inflammatory | skeletal hyperostosis idiopathic Diffuse | nervous system disorder Severe | Vascular Disease Severe
Item
subject has a history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory oa, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease.
boolean
C0003873 (UMLS CUI [1])
C0016053 (UMLS CUI [2])
C0009782 (UMLS CUI [3])
C0003872 (UMLS CUI [4])
C0451840 (UMLS CUI [5,1])
C0333348 (UMLS CUI [5,2])
C1399999 (UMLS CUI [6,1])
C0332240 (UMLS CUI [6,2])
C0205219 (UMLS CUI [6,3])
C0027765 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0042373 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
Gout | Pseudogout | Redness | Swelling | Fever
Item
subject has active (redness, swelling, fever, etc.) gout or pseudo-gout within 6 months prior to screening.
boolean
C0018099 (UMLS CUI [1])
C0033802 (UMLS CUI [2])
C0332575 (UMLS CUI [3])
C0038999 (UMLS CUI [4])
C0015967 (UMLS CUI [5])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Peripheral Neuropathy
Item
subject has type i or type ii diabetes with peripheral neuropathies.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0031117 (UMLS CUI [3])
Knee Injuries | Operative procedure on knee
Item
subject has had trauma or surgery to the knee(s) within 1 year prior to the enrollment period.
boolean
C0022744 (UMLS CUI [1])
C0187769 (UMLS CUI [2])
Condition Clinical Unstable | Malignant Neoplasms
Item
subject has an underlying clinical condition, including previous malignancies that in the investigator's judgment, is unstable.
boolean
C0348080 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
Hypersensitivity Capsicum extract | Hypersensitivity zucapsaicin | Hypersensitivity Product Capsaicin Containing | Hypersensitivity Capsaicin cream preparation Constituents
Item
subject has known allergy or hypersensitivity to capsicum, civamide, or capsaicin-containing products or any constituent of the cream formulation.
boolean
C0020517 (UMLS CUI [1,1])
C1095803 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0763832 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1514468 (UMLS CUI [3,2])
C0006931 (UMLS CUI [3,3])
C0332256 (UMLS CUI [3,4])
C0020517 (UMLS CUI [4,1])
C0006931 (UMLS CUI [4,2])
C0304245 (UMLS CUI [4,3])
C0729650 (UMLS CUI [4,4])
Substance Use Disorders
Item
subject has a history of substance abuse within the past 12 months.
boolean
C0038586 (UMLS CUI [1])
Pharmaceutical Preparations Use During Restriction Period
Item
use of certain medications within the given restriction period prior to randomization and during the study.
boolean
C0013227 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0443288 (UMLS CUI [1,4])
C1948053 (UMLS CUI [1,5])
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