ID

31290

Description

An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01728246

Link

https://clinicaltrials.gov/show/NCT01728246

Keywords

Versions (1)
  1. 8/9/18 8/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 9, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT01728246

English

Eligibility Osteoarthritis NCT01728246

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with chronic osteoarthritis of knee or hip for greater than (>) or equal to (=) 1 year (based on the american college of rheumatology (acr) diagnostic criteria for osteoarthritis), who are experiencing at least moderate osteoarthritis pain (>=50 millimeter [mm] in 100 mm visual analog scale [vas])
Description

Knee Osteoarthritis chronic Disease length | Osteoarthritis of hip chronic Disease length | Osteoarthritis Moderate pain Visual Analog Pain Scale | Osteoarthritis Severe pain Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0872146
UMLS CUI [2,1]
C0029410
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0872146
UMLS CUI [3,1]
C0029408
UMLS CUI [3,2]
C0278139
UMLS CUI [3,3]
C0042815
UMLS CUI [4,1]
C0029408
UMLS CUI [4,2]
C0278140
UMLS CUI [4,3]
C0042815
on any cyclooxygenase - 2 (cox-2) inhibitors for at least 2 weeks preceding the study
Description

Cyclooxygenase 2 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1257954
women with childbearing potential must have negative pregnancy test
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
women of child bearing potential must agree to use accepted methods of contraception
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
participant has signed the written informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants taking monoamine oxydase (mao) inhibitors, neuroleptics or drugs for seizures
Description

Monoamine Oxidase Inhibitors | Antipsychotic Agents | Anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0003286
severe hepatic impairment (the impaired ability of the liver to fulfill its role in metabolism)
Description

Hepatic impairment Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
on maintenance tramadol and/or paracetamol(apap)
Description

Maintenance therapy | Tramadol | Acetaminophen

Data type

boolean

Alias
UMLS CUI [1]
C0677908
UMLS CUI [2]
C0040610
UMLS CUI [3]
C0000970
on sedative hypnotics, short-acting analgesics, topical medications and anesthetics, and/or muscle relaxants
Description

Sedative Hypnotics | Analgesics, Short-Acting | Pharmaceutical Preparations Topical | Topical anesthetic | Muscle relaxants

Data type

boolean

Alias
UMLS CUI [1]
C0020592
UMLS CUI [2]
C3178868
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1522168
UMLS CUI [4]
C0040464
UMLS CUI [5]
C0358430
pregnant, lactating or breastfeeding participants
Description

Pregnancy | Lactation | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3]
C0006147
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Similar models

Eligibility Osteoarthritis NCT01728246

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis chronic Disease length | Osteoarthritis of hip chronic Disease length | Osteoarthritis Moderate pain Visual Analog Pain Scale | Osteoarthritis Severe pain Visual Analog Pain Scale
Item
diagnosed with chronic osteoarthritis of knee or hip for greater than (>) or equal to (=) 1 year (based on the american college of rheumatology (acr) diagnostic criteria for osteoarthritis), who are experiencing at least moderate osteoarthritis pain (>=50 millimeter [mm] in 100 mm visual analog scale [vas])
boolean
C0409959 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
C0029410 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0872146 (UMLS CUI [2,3])
C0029408 (UMLS CUI [3,1])
C0278139 (UMLS CUI [3,2])
C0042815 (UMLS CUI [3,3])
C0029408 (UMLS CUI [4,1])
C0278140 (UMLS CUI [4,2])
C0042815 (UMLS CUI [4,3])
Cyclooxygenase 2 Inhibitors
Item
on any cyclooxygenase - 2 (cox-2) inhibitors for at least 2 weeks preceding the study
boolean
C1257954 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
women with childbearing potential must have negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
women of child bearing potential must agree to use accepted methods of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
participant has signed the written informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Monoamine Oxidase Inhibitors | Antipsychotic Agents | Anticonvulsants
Item
participants taking monoamine oxydase (mao) inhibitors, neuroleptics or drugs for seizures
boolean
C0026457 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
Hepatic impairment Severe
Item
severe hepatic impairment (the impaired ability of the liver to fulfill its role in metabolism)
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Maintenance therapy | Tramadol | Acetaminophen
Item
on maintenance tramadol and/or paracetamol(apap)
boolean
C0677908 (UMLS CUI [1])
C0040610 (UMLS CUI [2])
C0000970 (UMLS CUI [3])
Sedative Hypnotics | Analgesics, Short-Acting | Pharmaceutical Preparations Topical | Topical anesthetic | Muscle relaxants
Item
on sedative hypnotics, short-acting analgesics, topical medications and anesthetics, and/or muscle relaxants
boolean
C0020592 (UMLS CUI [1])
C3178868 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1522168 (UMLS CUI [3,2])
C0040464 (UMLS CUI [4])
C0358430 (UMLS CUI [5])
Pregnancy | Lactation | Breast Feeding
Item
pregnant, lactating or breastfeeding participants
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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