ID

31303

Description

Tapentadol (CG5503); ODM derived from: https://clinicaltrials.gov/show/NCT00421928

Link

https://clinicaltrials.gov/show/NCT00421928

Keywords

Versions (1)
  1. 8/11/18 8/11/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 11, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT00421928

English

Eligibility Osteoarthritis, Knee NCT00421928

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with osteoarthritis of the knee based on the american college of rheumatology (acr) criteria and functional capacity class of i-iii
Description

Knee Osteoarthritis Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3177117
patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy
Description

Analgesics | Dissatisfaction Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0002771
UMLS CUI [2,1]
C0870433
UMLS CUI [2,2]
C0087111
patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to <160 mg of oral morphine
Description

Patient need for Opioids | Opioid Analgesics U/day | Oral Morphine Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0242402
UMLS CUI [2,1]
C0002772
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0360457
UMLS CUI [3,2]
C0205163
baseline score of greater than or equal to 5 on an 11-point numerical rating scale, calculated as the average pain intensity during the last 3 days prior to randomization.
Description

Average Severity of Pain Numeric Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C3641836
UMLS CUI [1,2]
C1518471
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of alcohol and/or drug abuse in investigator's judgement
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
history of significant liver insufficiency
Description

Hepatic Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1306571
chronic hepatitis b or c, or hiv, presence of active hepatitis b or c within the past 3 months
Description

Hepatitis B, Chronic | Hepatitis C, Chronic | Chronic infection with HIV | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0524910
UMLS CUI [3]
C0853112
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0019196
life-long history of seizure disorder or epilepsy
Description

Epilepsy Lifelong

Data type

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C4274169
history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
Description

Malignant Neoplasms | Exception Basal cell carcinoma Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
patients with severely impaired renal function
Description

Renal Insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function
Description

Liver Dysfunction Moderate | Liver Dysfunction Severe | Laboratory Results Consistent with Abnormal liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C1254595
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0086565
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Similar models

Eligibility Osteoarthritis, Knee NCT00421928

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis Kellgren-Lawrence score
Item
patients diagnosed with osteoarthritis of the knee based on the american college of rheumatology (acr) criteria and functional capacity class of i-iii
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
Analgesics | Dissatisfaction Therapy
Item
patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy
boolean
C0002771 (UMLS CUI [1])
C0870433 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Patient need for Opioids | Opioid Analgesics U/day | Oral Morphine Equivalent
Item
patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to <160 mg of oral morphine
boolean
C0686904 (UMLS CUI [1,1])
C0242402 (UMLS CUI [1,2])
C0002772 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0360457 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
Average Severity of Pain Numeric Pain Scale
Item
baseline score of greater than or equal to 5 on an 11-point numerical rating scale, calculated as the average pain intensity during the last 3 days prior to randomization.
boolean
C3641836 (UMLS CUI [1,1])
C1518471 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders
Item
history of alcohol and/or drug abuse in investigator's judgement
boolean
C0038586 (UMLS CUI [1])
Hepatic Insufficiency
Item
history of significant liver insufficiency
boolean
C1306571 (UMLS CUI [1])
Hepatitis B, Chronic | Hepatitis C, Chronic | Chronic infection with HIV | Hepatitis B | Hepatitis C
Item
chronic hepatitis b or c, or hiv, presence of active hepatitis b or c within the past 3 months
boolean
C0524909 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
C0853112 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
Epilepsy Lifelong
Item
life-long history of seizure disorder or epilepsy
boolean
C0014544 (UMLS CUI [1,1])
C4274169 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated
Item
history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Renal Insufficiency Severe
Item
patients with severely impaired renal function
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Liver Dysfunction Moderate | Liver Dysfunction Severe | Laboratory Results Consistent with Abnormal liver function
Item
patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1254595 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0086565 (UMLS CUI [3,3])
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