ID

42731

Beskrivning

Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 0.0125% of Capsaicin to Placebo; ODM derived from: https://clinicaltrials.gov/show/NCT00471055

Länk

https://clinicaltrials.gov/show/NCT00471055

Nyckelord

Versioner (2)
  1. 2017-08-19 2017-08-19 -
  2. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee Joint NCT00471055

Engelsk

Eligibility Osteoarthritis, Knee Joint NCT00471055

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects eligible for enrollment in the study must meet all of the following criteria:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
2. ambulatory nom pregnant females and males 40-<80 years of age.
Beskrivning

Ambulatory | Pregnancy Absent | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0439841
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0001779
3. subjects who withdraw pain medication or nutritional supplements for symptom relief for knee oa for a total of at least 15 days before screening visit 0.
Beskrivning

Analgesics Withdrawn | Dietary Supplements Withdrawn | Knee Osteoarthritis Symptoms relief

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0424092
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0424092
UMLS CUI [3,1]
C0409959
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C0564405
4. pain at or below 80 mm on a 100 mm vas in the index knee.
Beskrivning

Knee pain Visual Analog Pain Scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0042815
5. a documented diagnosis of oa of the knee, or meeting american college of rheumatology (acr) clinical criteria for classification of idiopathic (primary) oa for at least 6 months prior to screening. if oa is presented in both knees the investigator will identify which knee will be x-rayed for study entry, with preference for the knee with more severe pain (<80mm vas).
Beskrivning

Osteoarthritis, Knee | Idiopathic osteoarthritis Disease length | Radiography of knee

Datatyp

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2,1]
C0409952
UMLS CUI [2,2]
C0872146
UMLS CUI [3]
C0845957
6. has documented radiographic evidence of oa of the knee from the screening visit radiograph of grade 2 or 3 according to kellgren and lawrence radiographic grading.
Beskrivning

Knee Osteoarthritis Kellgren-Lawrence score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3177117
7. subjects with baseline minimum joint space width in the medial compartment of the index knee of > 1.5 mm at baseline, measured from radiographs using the mtp view.
Beskrivning

Joint space Width Minimum Medial compartment of knee | Radiography Knee Involved Metatarsophalangeal joint View

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0224497
UMLS CUI [1,2]
C0487742
UMLS CUI [1,3]
C1524031
UMLS CUI [1,4]
C0447799
UMLS CUI [2,1]
C0034571
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0025589
UMLS CUI [2,5]
C0449911
8. subjects with baseline minimum joint space width in the lateral compartment of the index knee of > 2.5 mm at baseline, measured from radiographs using the mtp view.
Beskrivning

Joint space Width Minimum Lateral compartment of knee | Radiography Knee Involved Metatarsophalangeal joint View

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0224497
UMLS CUI [1,2]
C0487742
UMLS CUI [1,3]
C1524031
UMLS CUI [1,4]
C0447800
UMLS CUI [2,1]
C0034571
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0025589
UMLS CUI [2,5]
C0449911
9. subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment.
Beskrivning

Comprehension Pain | Arthritis Evaluation Global | Therapy Outcome Assessment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0030193
UMLS CUI [2,1]
C0003864
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C2348867
UMLS CUI [3,1]
C1518681
UMLS CUI [3,2]
C1516048
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with any of the following criteria must not be enrolled in the study:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. subjects with history of hypersensitivity to capsaicin.
Beskrivning

Hypersensitivity Capsaicin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0006931
2. subjects with skin lesion at the index knee.
Beskrivning

Skin lesion Knee Involved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C1314939
3. a history of lower extremity surgery within 6 months prior to screening v0.
Beskrivning

Surgical procedure on lower extremity

Datatyp

boolean

Alias
UMLS CUI [1]
C0187763
4. significant prior injury to the index knee within 12 months prior to screening v0.
Beskrivning

Injury Knee Involved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3263723
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C1314939
5. disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
Beskrivning

Spinal Disease Affecting Knee Involved | Disease Lower extremity joint Affecting Knee Involved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037933
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0022742
UMLS CUI [1,4]
C1314939
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0584731
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0022742
UMLS CUI [2,5]
C1314939
6. treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
Beskrivning

Pharmaceutical Preparations Affecting Bone metabolism | Pharmaceutical Preparations Affecting Cartilage metabolism

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596204
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0596276
chronic systematic corticosteroids
Beskrivning

CORTICOSTEROIDS FOR SYSTEMIC USE chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0205191
hyaluronan injection into the index knee with in the previous 6 months.
Beskrivning

Hyaluronan Injection Knee Involved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020196
UMLS CUI [1,2]
C1828121
UMLS CUI [1,3]
C0022742
UMLS CUI [1,4]
C1314939
diacerin treatment within the last 12 months.
Beskrivning

diacetylrhein

Datatyp

boolean

Alias
UMLS CUI [1]
C0057678
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Similar models

Eligibility Osteoarthritis, Knee Joint NCT00471055

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
subjects eligible for enrollment in the study must meet all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent | Protocol Compliance
Item
1. subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Ambulatory | Pregnancy Absent | Age
Item
2. ambulatory nom pregnant females and males 40-<80 years of age.
boolean
C0439841 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Analgesics Withdrawn | Dietary Supplements Withdrawn | Knee Osteoarthritis Symptoms relief
Item
3. subjects who withdraw pain medication or nutritional supplements for symptom relief for knee oa for a total of at least 15 days before screening visit 0.
boolean
C0002771 (UMLS CUI [1,1])
C0424092 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2,1])
C0424092 (UMLS CUI [2,2])
C0409959 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0564405 (UMLS CUI [3,3])
Knee pain Visual Analog Pain Scale
Item
4. pain at or below 80 mm on a 100 mm vas in the index knee.
boolean
C0231749 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
Osteoarthritis, Knee | Idiopathic osteoarthritis Disease length | Radiography of knee
Item
5. a documented diagnosis of oa of the knee, or meeting american college of rheumatology (acr) clinical criteria for classification of idiopathic (primary) oa for at least 6 months prior to screening. if oa is presented in both knees the investigator will identify which knee will be x-rayed for study entry, with preference for the knee with more severe pain (<80mm vas).
boolean
C0409959 (UMLS CUI [1])
C0409952 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0845957 (UMLS CUI [3])
Knee Osteoarthritis Kellgren-Lawrence score
Item
6. has documented radiographic evidence of oa of the knee from the screening visit radiograph of grade 2 or 3 according to kellgren and lawrence radiographic grading.
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
Joint space Width Minimum Medial compartment of knee | Radiography Knee Involved Metatarsophalangeal joint View
Item
7. subjects with baseline minimum joint space width in the medial compartment of the index knee of > 1.5 mm at baseline, measured from radiographs using the mtp view.
boolean
C0224497 (UMLS CUI [1,1])
C0487742 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0447799 (UMLS CUI [1,4])
C0034571 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0025589 (UMLS CUI [2,4])
C0449911 (UMLS CUI [2,5])
Joint space Width Minimum Lateral compartment of knee | Radiography Knee Involved Metatarsophalangeal joint View
Item
8. subjects with baseline minimum joint space width in the lateral compartment of the index knee of > 2.5 mm at baseline, measured from radiographs using the mtp view.
boolean
C0224497 (UMLS CUI [1,1])
C0487742 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0447800 (UMLS CUI [1,4])
C0034571 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0025589 (UMLS CUI [2,4])
C0449911 (UMLS CUI [2,5])
Comprehension Pain | Arthritis Evaluation Global | Therapy Outcome Assessment
Item
9. subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment.
boolean
C0162340 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0003864 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C2348867 (UMLS CUI [2,3])
C1518681 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
subjects with any of the following criteria must not be enrolled in the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Hypersensitivity Capsaicin
Item
1. subjects with history of hypersensitivity to capsaicin.
boolean
C0020517 (UMLS CUI [1,1])
C0006931 (UMLS CUI [1,2])
Skin lesion Knee Involved
Item
2. subjects with skin lesion at the index knee.
boolean
C0037284 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Surgical procedure on lower extremity
Item
3. a history of lower extremity surgery within 6 months prior to screening v0.
boolean
C0187763 (UMLS CUI [1])
Injury Knee Involved
Item
4. significant prior injury to the index knee within 12 months prior to screening v0.
boolean
C3263723 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Spinal Disease Affecting Knee Involved | Disease Lower extremity joint Affecting Knee Involved
Item
5. disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
boolean
C0037933 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0584731 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0022742 (UMLS CUI [2,4])
C1314939 (UMLS CUI [2,5])
Pharmaceutical Preparations Affecting Bone metabolism | Pharmaceutical Preparations Affecting Cartilage metabolism
Item
6. treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596276 (UMLS CUI [2,3])
CORTICOSTEROIDS FOR SYSTEMIC USE chronic
Item
chronic systematic corticosteroids
boolean
C3653708 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Hyaluronan Injection Knee Involved
Item
hyaluronan injection into the index knee with in the previous 6 months.
boolean
C0020196 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
diacetylrhein
Item
diacerin treatment within the last 12 months.
boolean
C0057678 (UMLS CUI [1])
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