ID

36719

Description

A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee; ODM derived from: https://clinicaltrials.gov/show/NCT02068599

Link

https://clinicaltrials.gov/show/NCT02068599

Keywords

Versions (1)
  1. 6/4/19 6/4/19 -
Copyright Holder

See clinicaltrials.gov

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June 4, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT02068599

English

Eligibility Osteoarthritis of the Knee NCT02068599

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is between 40 and 85 years of age, patient has primary oa in a single knee (target knee) confirmed by american college of rheumatology criteria.
Description

Age | Unilateral primary osteoarthritis of knee

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2893932
for patients taking non-steroidal anti-inflammatory drugs (nsaids) or other analgesics at the time of the screening visit,
Description

Anti-Inflammatory Agents, Non-Steroidal | Analgesics

Data type

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0002771
patient has visual analog scale (vas) pain scores with acceptable ranges as determined by the investigator during screening
Description

Visual Analog Pain Scale Range Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0042815
UMLS CUI [1,2]
C1514721
UMLS CUI [1,3]
C1879533
except for oa, patient is judged by the investigator to be medically healthy and able to participate in the study.
Description

Exception Osteoarthritis | Patient Healthy

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0029408
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C3898900
other criteria apply, please contact the investigator for additional information
Description

Inclusion criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has secondary or inflammatory arthritis of the knee such as psoriasis, rheumatoid arthritis (ra), gout, other primary bone disease, or acute trauma.
Description

Arthritis of knee Secondary | Arthritis of knee inflammatory | Psoriasis | Rheumatoid Arthritis | Gout | Bone Disease Primary | Trauma

Data type

boolean

Alias
UMLS CUI [1,1]
C0240111
UMLS CUI [1,2]
C0175668
UMLS CUI [2,1]
C0240111
UMLS CUI [2,2]
C0333348
UMLS CUI [3]
C0033860
UMLS CUI [4]
C0003873
UMLS CUI [5]
C0018099
UMLS CUI [6,1]
C0005940
UMLS CUI [6,2]
C0205225
UMLS CUI [7]
C3714660
patient has symptomatic chondrocalcinosis
Description

Chondrocalcinosis Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0221621
UMLS CUI [1,2]
C0231220
patient has a history of fibromyalgia.
Description

Fibromyalgia

Data type

boolean

Alias
UMLS CUI [1]
C0016053
patient has any painful or disabling conditions that in the opinion of the investigator may confound assessment of pain scoring.
Description

Condition painful | Disabling condition | Interference Assessment Pain scoring

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0030193
UMLS CUI [2]
C4061999
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C1516048
UMLS CUI [3,3]
C0582148
patient has uncontrolled cardiac, renal, hepatic or other systemic disorders that in the opinion of the investigator may jeopardize the patient.
Description

Heart Disease Uncontrolled At risk Patient | Kidney Disease Uncontrolled At risk Patient | Liver disease Uncontrolled At risk Patient | Systemic disease Uncontrolled At risk Patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0030705
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0030705
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C1444641
UMLS CUI [3,4]
C0030705
UMLS CUI [4,1]
C0442893
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C1444641
UMLS CUI [4,4]
C0030705
patient has significant edema or skin disorder (including sores, rashes, or ulcers) at the target knee and surrounding area.
Description

Edema Target Knee | Dermatologic disorders Target Knee | Pressure Ulcer | Exanthema | Ulcer

Data type

boolean

Alias
UMLS CUI [1,1]
C0013604
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
UMLS CUI [2,1]
C0037274
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0022742
UMLS CUI [3]
C0011127
UMLS CUI [4]
C0015230
UMLS CUI [5]
C0041582
patient has a history of total or partial knee replacement in either leg.
Description

Total Knee Replacement Leg Either | Partial Knee Replacement Leg Either

Data type

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C0023216
UMLS CUI [1,3]
C3844638
UMLS CUI [2,1]
C0864243
UMLS CUI [2,2]
C0023216
UMLS CUI [2,3]
C3844638
patient had a major reconstructive knee surgery or arthroscopy of the target knee within 6 months before the screening visit.
Description

KNEE SURGERY RECONSTRUCTIVE Target Knee | Arthroscopy Target Knee

Data type

boolean

Alias
UMLS CUI [1,1]
C0745580
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
UMLS CUI [2,1]
C0003904
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0022742
patient is unable or unwilling to discontinue opioid and/or other prescription analgesics for control of oa pain.
Description

Opioids Discontinue Unable | Opioids Discontinue Unwilling | Analgesics Discontinue Unable | Analgesics Discontinue Unwilling | Control Osteoarthritis Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0242402
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0242402
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0002771
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0002771
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C0558080
UMLS CUI [5,1]
C0243148
UMLS CUI [5,2]
C0029408
UMLS CUI [5,3]
C0030193
patient is intolerant to study drug, its excipients, and/or acetaminophen.
Description

Intolerance to Investigational New Drugs | Intolerance to Investigational New Drug Excipient | Intolerance to Acetaminophen

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0000970
patient uses any over the counter oral medications such as glucosamine or chondroitin sulfate products, unless the patient has been receiving the medication for ≥3 months at the time of the screening visit and maintains the medication as stable therapy for the duration of the study.
Description

Non-Prescription Drugs Oral | Glucosamine | Chondroitin Sulfates | Exception Therapy Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C1272919
UMLS CUI [2]
C0017718
UMLS CUI [3]
C0008466
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0205360
other criteria apply, please contact the investigator for additional information
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Osteoarthritis of the Knee NCT02068599

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Unilateral primary osteoarthritis of knee
Item
patient is between 40 and 85 years of age, patient has primary oa in a single knee (target knee) confirmed by american college of rheumatology criteria.
boolean
C0001779 (UMLS CUI [1])
C2893932 (UMLS CUI [2])
Anti-Inflammatory Agents, Non-Steroidal | Analgesics
Item
for patients taking non-steroidal anti-inflammatory drugs (nsaids) or other analgesics at the time of the screening visit,
boolean
C0003211 (UMLS CUI [1])
C0002771 (UMLS CUI [2])
Visual Analog Pain Scale Range Acceptable
Item
patient has visual analog scale (vas) pain scores with acceptable ranges as determined by the investigator during screening
boolean
C0042815 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
Exception Osteoarthritis | Patient Healthy
Item
except for oa, patient is judged by the investigator to be medically healthy and able to participate in the study.
boolean
C1705847 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C3898900 (UMLS CUI [2,2])
Inclusion criteria Additional
Item
other criteria apply, please contact the investigator for additional information
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Arthritis of knee Secondary | Arthritis of knee inflammatory | Psoriasis | Rheumatoid Arthritis | Gout | Bone Disease Primary | Trauma
Item
patient has secondary or inflammatory arthritis of the knee such as psoriasis, rheumatoid arthritis (ra), gout, other primary bone disease, or acute trauma.
boolean
C0240111 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0240111 (UMLS CUI [2,1])
C0333348 (UMLS CUI [2,2])
C0033860 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
C0018099 (UMLS CUI [5])
C0005940 (UMLS CUI [6,1])
C0205225 (UMLS CUI [6,2])
C3714660 (UMLS CUI [7])
Chondrocalcinosis Symptomatic
Item
patient has symptomatic chondrocalcinosis
boolean
C0221621 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Fibromyalgia
Item
patient has a history of fibromyalgia.
boolean
C0016053 (UMLS CUI [1])
Condition painful | Disabling condition | Interference Assessment Pain scoring
Item
patient has any painful or disabling conditions that in the opinion of the investigator may confound assessment of pain scoring.
boolean
C0348080 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C4061999 (UMLS CUI [2])
C0521102 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C0582148 (UMLS CUI [3,3])
Heart Disease Uncontrolled At risk Patient | Kidney Disease Uncontrolled At risk Patient | Liver disease Uncontrolled At risk Patient | Systemic disease Uncontrolled At risk Patient
Item
patient has uncontrolled cardiac, renal, hepatic or other systemic disorders that in the opinion of the investigator may jeopardize the patient.
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
C0022658 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0030705 (UMLS CUI [2,4])
C0023895 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0030705 (UMLS CUI [3,4])
C0442893 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0030705 (UMLS CUI [4,4])
Edema Target Knee | Dermatologic disorders Target Knee | Pressure Ulcer | Exanthema | Ulcer
Item
patient has significant edema or skin disorder (including sores, rashes, or ulcers) at the target knee and surrounding area.
boolean
C0013604 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0037274 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C0011127 (UMLS CUI [3])
C0015230 (UMLS CUI [4])
C0041582 (UMLS CUI [5])
Total Knee Replacement Leg Either | Partial Knee Replacement Leg Either
Item
patient has a history of total or partial knee replacement in either leg.
boolean
C0086511 (UMLS CUI [1,1])
C0023216 (UMLS CUI [1,2])
C3844638 (UMLS CUI [1,3])
C0864243 (UMLS CUI [2,1])
C0023216 (UMLS CUI [2,2])
C3844638 (UMLS CUI [2,3])
KNEE SURGERY RECONSTRUCTIVE Target Knee | Arthroscopy Target Knee
Item
patient had a major reconstructive knee surgery or arthroscopy of the target knee within 6 months before the screening visit.
boolean
C0745580 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0003904 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
Opioids Discontinue Unable | Opioids Discontinue Unwilling | Analgesics Discontinue Unable | Analgesics Discontinue Unwilling | Control Osteoarthritis Pain
Item
patient is unable or unwilling to discontinue opioid and/or other prescription analgesics for control of oa pain.
boolean
C0242402 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0242402 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0002771 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0002771 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C0243148 (UMLS CUI [5,1])
C0029408 (UMLS CUI [5,2])
C0030193 (UMLS CUI [5,3])
Intolerance to Investigational New Drugs | Intolerance to Investigational New Drug Excipient | Intolerance to Acetaminophen
Item
patient is intolerant to study drug, its excipients, and/or acetaminophen.
boolean
C1744706 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C1744706 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
Non-Prescription Drugs Oral | Glucosamine | Chondroitin Sulfates | Exception Therapy Stable
Item
patient uses any over the counter oral medications such as glucosamine or chondroitin sulfate products, unless the patient has been receiving the medication for ≥3 months at the time of the screening visit and maintains the medication as stable therapy for the duration of the study.
boolean
C0013231 (UMLS CUI [1,1])
C1272919 (UMLS CUI [1,2])
C0017718 (UMLS CUI [2])
C0008466 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Exclusion Criteria Additional
Item
other criteria apply, please contact the investigator for additional information
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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