ID

24876

Descrição

Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00980798

Link

https://clinicaltrials.gov/show/NCT00980798

Palavras-chave

Versões (1)
  1. 21/08/2017 21/08/2017 -
Transferido a

21 de agosto de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Pain NCT00980798

Inglês

Eligibility Pain NCT00980798

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Pain NCT00980798
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented osteoarthritis of the hip or knee
Descrição

Osteoarthritis of hip | Osteoarthritis, Knee

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029410
UMLS CUI [2]
C0409959
chronic pain for more than 3 months treated with daily analgesic for the last month
Descrição

Chronic pain Duration | Analgesics Daily

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0150055
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0002771
UMLS CUI [2,2]
C0332173
moderate to severe oa pain of the target joint, which cannot be adequately treated with non-steroidal anti-inflamatory drugs or paracetamol
Descrição

Moderate pain Osteoarthritis Target Joint | Severe pain Osteoarthritis Target Joint | Anti-Inflammatory Agents, Non-Steroidal | Acetaminophen | Therapeutic procedure Inadequate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0278139
UMLS CUI [1,2]
C0029408
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0022417
UMLS CUI [2,1]
C0278140
UMLS CUI [2,2]
C0029408
UMLS CUI [2,3]
C1521840
UMLS CUI [2,4]
C0022417
UMLS CUI [3]
C0003211
UMLS CUI [4]
C0000970
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0205412
moderate to severe pain by means of a mean weekly score of >= 5 in the brief pain invetory item 5 'pain on average'
Descrição

Moderate pain Brief pain inventory score | Severe pain Brief pain inventory score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0278139
UMLS CUI [1,2]
C2732532
UMLS CUI [2,1]
C0278140
UMLS CUI [2,2]
C2732532
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
regular treatment with an opioid in the 4 weeks before screening visit (infrequent use of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4 weeks before the screening visit is acceptable, however, treatment must be stopped at screening visit)
Descrição

Opioids Regular | Tramadol | Codeine | Tilidine | dihydrocodeine | Therapeutic procedure To be stopped

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242402
UMLS CUI [1,2]
C0205272
UMLS CUI [2]
C0040610
UMLS CUI [3]
C0009214
UMLS CUI [4]
C0040219
UMLS CUI [5]
C0058056
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C1272691
diagnosis of major depression
Descrição

Major Depressive Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1269683
treatment for epilepsy
Descrição

Therapeutic procedure Epilepsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0014544
corticosteroid injection within the last 3 months
Descrição

Adrenal Cortex Hormones Injection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1828121
major surgery in the 3 months before the start of the study
Descrição

major surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
women who are pregnant or breast-feeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Eligibility Pain NCT00980798

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Pain NCT00980798
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Osteoarthritis of hip | Osteoarthritis, Knee
Item
documented osteoarthritis of the hip or knee
boolean
C0029410 (UMLS CUI [1])
C0409959 (UMLS CUI [2])
Chronic pain Duration | Analgesics Daily
Item
chronic pain for more than 3 months treated with daily analgesic for the last month
boolean
C0150055 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0002771 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
Moderate pain Osteoarthritis Target Joint | Severe pain Osteoarthritis Target Joint | Anti-Inflammatory Agents, Non-Steroidal | Acetaminophen | Therapeutic procedure Inadequate
Item
moderate to severe oa pain of the target joint, which cannot be adequately treated with non-steroidal anti-inflamatory drugs or paracetamol
boolean
C0278139 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0022417 (UMLS CUI [1,4])
C0278140 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C1521840 (UMLS CUI [2,3])
C0022417 (UMLS CUI [2,4])
C0003211 (UMLS CUI [3])
C0000970 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C0205412 (UMLS CUI [5,2])
Moderate pain Brief pain inventory score | Severe pain Brief pain inventory score
Item
moderate to severe pain by means of a mean weekly score of >= 5 in the brief pain invetory item 5 'pain on average'
boolean
C0278139 (UMLS CUI [1,1])
C2732532 (UMLS CUI [1,2])
C0278140 (UMLS CUI [2,1])
C2732532 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Opioids Regular | Tramadol | Codeine | Tilidine | dihydrocodeine | Therapeutic procedure To be stopped
Item
regular treatment with an opioid in the 4 weeks before screening visit (infrequent use of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4 weeks before the screening visit is acceptable, however, treatment must be stopped at screening visit)
boolean
C0242402 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0040610 (UMLS CUI [2])
C0009214 (UMLS CUI [3])
C0040219 (UMLS CUI [4])
C0058056 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
Major Depressive Disorder
Item
diagnosis of major depression
boolean
C1269683 (UMLS CUI [1])
Therapeutic procedure Epilepsy
Item
treatment for epilepsy
boolean
C0087111 (UMLS CUI [1,1])
C0014544 (UMLS CUI [1,2])
Adrenal Cortex Hormones Injection
Item
corticosteroid injection within the last 3 months
boolean
C0001617 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
major surgery
Item
major surgery in the 3 months before the start of the study
boolean
C0679637 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
women who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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