ID

31311

Beschreibung

A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00669409

Link

https://clinicaltrials.gov/show/NCT00669409

Stichworte

Versionen (1)
  1. 12.08.18 12.08.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. August 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT00669409

Englisch

Eligibility Osteoarthritis, Knee NCT00669409

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
japanese male or female, age 35-65 (part 1), age 35-75 (part 2)
Beschreibung

Japanese | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2]
C0001779
diagnosis of osteoarthritis (oa) of the knee based on american college of rheumatology criteria
Beschreibung

Osteoarthritis, Knee

Datentyp

boolean

Alias
UMLS CUI [1]
C0409959
knee pain, and radiographic evidence of knee oa (kellgren-lawrence x-ray grade ≥2) obtained within 1 year of enrollment
Beschreibung

Knee pain | Knee Osteoarthritis Kellgren-Lawrence score Radiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0231749
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C3177117
UMLS CUI [2,3]
C0034571
at least one of the following: age >50, morning stiffness <30 minutes in duration, crepitus, and oa of the knee must involve the index tibiofemoral joint and must have present for at least 6 months
Beschreibung

Age | Morning stiffness Duration | Joint crepitus | Knee Osteoarthritis Involving Index Tibiofemoral joint | Knee Osteoarthritis Disease length

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0457086
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0231592
UMLS CUI [4,1]
C0409959
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C2986546
UMLS CUI [4,4]
C0447795
UMLS CUI [5,1]
C0409959
UMLS CUI [5,2]
C0872146
patients who meet at least one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery
Beschreibung

Unwilling Analgesics Except Opiates | Analgesics Except Opiates failed | Invasive procedure intended | Intra-Articular Injections | Knee Arthroplasty | Operative procedure on knee Total

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0002771
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C0376196
UMLS CUI [2,1]
C0002771
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0376196
UMLS CUI [2,4]
C0231175
UMLS CUI [3,1]
C4048276
UMLS CUI [3,2]
C1283828
UMLS CUI [4]
C0021488
UMLS CUI [5]
C0086511
UMLS CUI [6,1]
C0187769
UMLS CUI [6,2]
C0439810
pain levels as required by the protocol at screening and baseline
Beschreibung

Pain level Study Protocol Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518087
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C1514873
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis or history of ra, any inflammatory arthritis, gout, paget's disease or any other disease that in the investigator's opinion would interfere with the assessment of pain and other symptoms of oa
Beschreibung

Rheumatoid Arthritis | Arthritis | Gout | Paget Disease | Disease Interferes with Pain assessment | Disease Interferes with Symptom Assessment Osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0003864
UMLS CUI [3]
C0018099
UMLS CUI [4]
C1368019
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0030198
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C3494437
UMLS CUI [6,4]
C0029408
patients with regional pain syndromes suggestive of fibromyalgia or regional pain caused by lumbar or cervical compressions with radiculopathy or at risk of developing radiculopathy.
Beschreibung

Regional pain syndrome Suggestive of Fibromyalgia | Pain regional caused by LUMBAR SPINAL CORD COMPRESSION | Pain regional caused by Cervical cord compression | Radiculopathy | At risk Radiculopathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0850603
UMLS CUI [1,2]
C0332299
UMLS CUI [1,3]
C0016053
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0205147
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C0745990
UMLS CUI [3,1]
C0030193
UMLS CUI [3,2]
C0205147
UMLS CUI [3,3]
C0015127
UMLS CUI [3,4]
C0852866
UMLS CUI [4]
C0700594
UMLS CUI [5,1]
C1444641
UMLS CUI [5,2]
C0700594
diagnosis or history of fibromyalgia
Beschreibung

Fibromyalgia

Datentyp

boolean

Alias
UMLS CUI [1]
C0016053
planned surgical procedure during the duration of the study
Beschreibung

Operative Surgical Procedure Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
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Ähnliche Modelle

Eligibility Osteoarthritis, Knee NCT00669409

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Japanese | Age
Item
japanese male or female, age 35-65 (part 1), age 35-75 (part 2)
boolean
C1556094 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Osteoarthritis, Knee
Item
diagnosis of osteoarthritis (oa) of the knee based on american college of rheumatology criteria
boolean
C0409959 (UMLS CUI [1])
Knee pain | Knee Osteoarthritis Kellgren-Lawrence score Radiography
Item
knee pain, and radiographic evidence of knee oa (kellgren-lawrence x-ray grade ≥2) obtained within 1 year of enrollment
boolean
C0231749 (UMLS CUI [1])
C0409959 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
Age | Morning stiffness Duration | Joint crepitus | Knee Osteoarthritis Involving Index Tibiofemoral joint | Knee Osteoarthritis Disease length
Item
at least one of the following: age >50, morning stiffness <30 minutes in duration, crepitus, and oa of the knee must involve the index tibiofemoral joint and must have present for at least 6 months
boolean
C0001779 (UMLS CUI [1])
C0457086 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0231592 (UMLS CUI [3])
C0409959 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C2986546 (UMLS CUI [4,3])
C0447795 (UMLS CUI [4,4])
C0409959 (UMLS CUI [5,1])
C0872146 (UMLS CUI [5,2])
Unwilling Analgesics Except Opiates | Analgesics Except Opiates failed | Invasive procedure intended | Intra-Articular Injections | Knee Arthroplasty | Operative procedure on knee Total
Item
patients who meet at least one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery
boolean
C0558080 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0376196 (UMLS CUI [1,4])
C0002771 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0376196 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
C4048276 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0021488 (UMLS CUI [4])
C0086511 (UMLS CUI [5])
C0187769 (UMLS CUI [6,1])
C0439810 (UMLS CUI [6,2])
Pain level Study Protocol Required
Item
pain levels as required by the protocol at screening and baseline
boolean
C0518087 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Rheumatoid Arthritis | Arthritis | Gout | Paget Disease | Disease Interferes with Pain assessment | Disease Interferes with Symptom Assessment Osteoarthritis
Item
diagnosis or history of ra, any inflammatory arthritis, gout, paget's disease or any other disease that in the investigator's opinion would interfere with the assessment of pain and other symptoms of oa
boolean
C0003873 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C1368019 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0030198 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3494437 (UMLS CUI [6,3])
C0029408 (UMLS CUI [6,4])
Regional pain syndrome Suggestive of Fibromyalgia | Pain regional caused by LUMBAR SPINAL CORD COMPRESSION | Pain regional caused by Cervical cord compression | Radiculopathy | At risk Radiculopathy
Item
patients with regional pain syndromes suggestive of fibromyalgia or regional pain caused by lumbar or cervical compressions with radiculopathy or at risk of developing radiculopathy.
boolean
C0850603 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0016053 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C0745990 (UMLS CUI [2,4])
C0030193 (UMLS CUI [3,1])
C0205147 (UMLS CUI [3,2])
C0015127 (UMLS CUI [3,3])
C0852866 (UMLS CUI [3,4])
C0700594 (UMLS CUI [4])
C1444641 (UMLS CUI [5,1])
C0700594 (UMLS CUI [5,2])
Fibromyalgia
Item
diagnosis or history of fibromyalgia
boolean
C0016053 (UMLS CUI [1])
Operative Surgical Procedure Planned
Item
planned surgical procedure during the duration of the study
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
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