ID

40752

Description

Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels; ODM derived from: https://clinicaltrials.gov/show/NCT01836393

Link

https://clinicaltrials.gov/show/NCT01836393

Keywords

Versions (1)
  1. 5/8/20 5/8/20 -
Copyright Holder

See clinicaltrials.gov

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May 8, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01836393

English

Eligibility Knee Osteoarthritis NCT01836393

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects eligible for enrollment in the study met all of the following criteria:
Description

Inclusion criteria All Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1550543
1. subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Description

Informed Consent | Protocol Compliance

Data type

boolean

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

Ambulatory | Gender | Pregnancy Absent | Age

Data type

boolean

Alias
UMLS CUI [1]
C1561561
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
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.
Description

Analgesics Withdrawn | Dietary Supplements Withdrawn | Symptom relief Knee Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C2349954
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C2349954
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0564405
UMLS CUI [3,3]
C0409959
4. pain at or below 80 mm on a 100 mm vas in the index knee.
Description

Pain Visual Analog Pain Scale | Pain Knee Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0042815
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0392760
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).
Description

Osteoarthritis, Knee | Idiopathic osteoarthritis ACR Criteria | Knee X-Ray Computed Tomography | Knee pain Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2,1]
C0409952
UMLS CUI [2,2]
C3273747
UMLS CUI [3,1]
C0022742
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C0231749
UMLS CUI [4,2]
C0042815
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 (11)
Description

Knee Osteoarthritis Kellgren-Lawrence score Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3177117
UMLS CUI [1,3]
C0034571
7. subjects with baseline minimum joint space width in the medial and lateral compartments of the index knee of > 1.5 mm and > 2.5 mm at baseline respectively, measured from radiographs using the mtp view.
Description

Joint space Width Minimum | Medial compartment of knee | Lateral compartment of knee | Radiography Metatarsophalangeal joint

Data type

boolean

Alias
UMLS CUI [1,1]
C0224497
UMLS CUI [1,2]
C0487742
UMLS CUI [1,3]
C1524031
UMLS CUI [2]
C0447799
UMLS CUI [3]
C0447800
UMLS CUI [4,1]
C0034571
UMLS CUI [4,2]
C0025589
Exclusion Criteria
Description

Exclusion Criteria

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

Exclusion Criteria Any Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
1. subjects with history of hypersensitivity to plai.
Description

Hypersensitivity Zingiber montanum

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1891634
2. subjects with skin lesion at the index knee.
Description

Skin lesion Knee Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0392760
3. a history of lower extremity surgery within 6 months prior to screening.
Description

Surgical procedure on lower extremity

Data type

boolean

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

Injury Knee Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C3263723
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0392760
5. disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
Description

Spinal Disease Affecting Knee | Disease Lower extremity joint Affecting Knee

Data type

boolean

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

Pharmaceutical Preparations Affecting Bone metabolism | Pharmaceutical Preparations Affecting Cartilage metabolism

Data type

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
Description

CORTICOSTEROIDS FOR SYSTEMIC USE chronic

Data type

boolean

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

Hyaluronic Acid Injection | Knee Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C0020196
UMLS CUI [1,2]
C1828121
UMLS CUI [2,1]
C0022742
UMLS CUI [2,2]
C0392760
diacerin or glucosamine treatment within the last 12 months.
Description

diacerein | Glucosamine

Data type

boolean

Alias
UMLS CUI [1]
C0057678
UMLS CUI [2]
C0017718
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Similar models

Eligibility Knee Osteoarthritis NCT01836393

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria All Fulfill
Item
subjects eligible for enrollment in the study met all of the following criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
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 | Gender | Pregnancy Absent | Age
Item
2. ambulatory nom pregnant females and males 40-<80 years of age.
boolean
C1561561 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Analgesics Withdrawn | Dietary Supplements Withdrawn | Symptom relief Knee Osteoarthritis
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.
boolean
C0002771 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0564405 (UMLS CUI [3,2])
C0409959 (UMLS CUI [3,3])
Pain Visual Analog Pain Scale | Pain Knee Affected
Item
4. pain at or below 80 mm on a 100 mm vas in the index knee.
boolean
C0030193 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
Osteoarthritis, Knee | Idiopathic osteoarthritis ACR Criteria | Knee X-Ray Computed Tomography | Knee pain Visual Analog Pain Scale
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])
C3273747 (UMLS CUI [2,2])
C0022742 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0231749 (UMLS CUI [4,1])
C0042815 (UMLS CUI [4,2])
Knee Osteoarthritis Kellgren-Lawrence score Radiography
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 (11)
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
Joint space Width Minimum | Medial compartment of knee | Lateral compartment of knee | Radiography Metatarsophalangeal joint
Item
7. subjects with baseline minimum joint space width in the medial and lateral compartments of the index knee of > 1.5 mm and > 2.5 mm at baseline respectively, 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 [2])
C0447800 (UMLS CUI [3])
C0034571 (UMLS CUI [4,1])
C0025589 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Any Fulfill
Item
subjects with any of the following criteria must not be enrolled in the study:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hypersensitivity Zingiber montanum
Item
1. subjects with history of hypersensitivity to plai.
boolean
C0020517 (UMLS CUI [1,1])
C1891634 (UMLS CUI [1,2])
Skin lesion Knee Affected
Item
2. subjects with skin lesion at the index knee.
boolean
C0037284 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Surgical procedure on lower extremity
Item
3. a history of lower extremity surgery within 6 months prior to screening.
boolean
C0187763 (UMLS CUI [1])
Injury Knee Affected
Item
4. significant prior injury to the index knee within 12 months prior to screening
boolean
C3263723 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Spinal Disease Affecting Knee | Disease Lower extremity joint Affecting Knee
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])
C0012634 (UMLS CUI [2,1])
C0584731 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0022742 (UMLS CUI [2,4])
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])
Hyaluronic Acid Injection | Knee Affected
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 [2,1])
C0392760 (UMLS CUI [2,2])
diacerein | Glucosamine
Item
diacerin or glucosamine treatment within the last 12 months.
boolean
C0057678 (UMLS CUI [1])
C0017718 (UMLS CUI [2])
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