ID

43906

Beschreibung

A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis (MK-0822-011); ODM derived from: https://clinicaltrials.gov/show/NCT00397683

Link

https://clinicaltrials.gov/show/NCT00397683

Stichworte

Versionen (2)
  1. 26.05.17 26.05.17 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00397683

Englisch

Eligibility Osteoarthritis NCT00397683

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with symptomatic knee osteoarthritis for at least 6 months based on clinical and radiographic criteria
Beschreibung

Knee Osteoarthritis Symptomatic Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0449238
patients should be in general good health and must have a certain level of knee pain or be taking pain medicines on most days
Beschreibung

General health good | Knee pain Level | Analgesics Frequency

Datentyp

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C0231749
UMLS CUI [2,2]
C0441889
UMLS CUI [3,1]
C0002771
UMLS CUI [3,2]
C0376249
specific radiographic (x-ray) and mri features must also be satisfied
Beschreibung

Feature Radiography Specific | Feature Magnetic Resonance Imaging Specific

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348519
UMLS CUI [1,2]
C0034571
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C2348519
UMLS CUI [2,2]
C0024485
UMLS CUI [2,3]
C0205369
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
non-osteoarthritic causes of knee pain
Beschreibung

Knee pain Causes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0015127
ineligibility to undergo mri of the knee due to patient tolerability or safety reasons
Beschreibung

Ineligibility MRI Knee | Ineligibility Due to Patient safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0022742
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1113679
previous septic arthritis, tibial osteotomy or knee replacement in both knees
Beschreibung

Arthritis, Infectious | Osteotomy of tibia | Knee Replacement Both knees

Datentyp

boolean

Alias
UMLS CUI [1]
C0003869
UMLS CUI [2]
C0187826
UMLS CUI [3,1]
C0086511
UMLS CUI [3,2]
C0230434
acute injury of knee ligaments or meniscus in past 2 years
Beschreibung

Injury of ligament of knee | Meniscus injury

Datentyp

boolean

Alias
UMLS CUI [1]
C0877583
UMLS CUI [2]
C1096124
knee arthroscopy in past 12 months
Beschreibung

Arthroscopy of knee

Datentyp

boolean

Alias
UMLS CUI [1]
C1304878
anticipated arthroscopy or surgery in next 18 months
Beschreibung

Arthroscopy Anticipated | Operative Surgical Procedures Anticipated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003904
UMLS CUI [1,2]
C3840775
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C3840775
use of intra-articular injections of hyaluronan (e.g. hyalgan (tm), synvisc (tm), orthovisc (tm)) in past 6 months, or injections of glucocorticoids (e.g. kenalog (tm), aristospan (tm), depo-medrol (tm)) in past 3 months or anticipated knee injections during the study
Beschreibung

Hyaluronan Intra-Articular Injection | Hyalgan Intra-Articular Injection | Synvisc Intra-Articular Injection | Orthovisc Intra-Articular Injection | Glucocorticoids Injection | Kenalog Injection | Aristospan Injection | Depo-Medrol Injection | Knee injection Anticipated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020196
UMLS CUI [1,2]
C0021488
UMLS CUI [2,1]
C0598621
UMLS CUI [2,2]
C0021488
UMLS CUI [3,1]
C0723570
UMLS CUI [3,2]
C0021488
UMLS CUI [4,1]
C1311677
UMLS CUI [4,2]
C0021488
UMLS CUI [5,1]
C0017710
UMLS CUI [5,2]
C1828121
UMLS CUI [6,1]
C0699689
UMLS CUI [6,2]
C1828121
UMLS CUI [7]
C0718654
UMLS CUI [8,1]
C0057476
UMLS CUI [8,2]
C1828121
UMLS CUI [9,1]
C0187946
UMLS CUI [9,2]
C3840775
glucosamine or chondroitin sulfate are allowable if they are at a stable dose for past 3 months and will continue at that dose during the study
Beschreibung

Glucosamine Dose Stable | Chondroitin Sulfates Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017718
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0008466
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
other exclusion criteria apply-please ask the study doctor for details
Beschreibung

Exclusion Criteria Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Ähnliche Modelle

Eligibility Osteoarthritis NCT00397683

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis Symptomatic Duration
Item
patients with symptomatic knee osteoarthritis for at least 6 months based on clinical and radiographic criteria
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
General health good | Knee pain Level | Analgesics Frequency
Item
patients should be in general good health and must have a certain level of knee pain or be taking pain medicines on most days
boolean
C1277245 (UMLS CUI [1])
C0231749 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0002771 (UMLS CUI [3,1])
C0376249 (UMLS CUI [3,2])
Feature Radiography Specific | Feature Magnetic Resonance Imaging Specific
Item
specific radiographic (x-ray) and mri features must also be satisfied
boolean
C2348519 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C2348519 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Knee pain Causes
Item
non-osteoarthritic causes of knee pain
boolean
C0231749 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Ineligibility MRI Knee | Ineligibility Due to Patient safety
Item
ineligibility to undergo mri of the knee due to patient tolerability or safety reasons
boolean
C1512714 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C1512714 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Arthritis, Infectious | Osteotomy of tibia | Knee Replacement Both knees
Item
previous septic arthritis, tibial osteotomy or knee replacement in both knees
boolean
C0003869 (UMLS CUI [1])
C0187826 (UMLS CUI [2])
C0086511 (UMLS CUI [3,1])
C0230434 (UMLS CUI [3,2])
Injury of ligament of knee | Meniscus injury
Item
acute injury of knee ligaments or meniscus in past 2 years
boolean
C0877583 (UMLS CUI [1])
C1096124 (UMLS CUI [2])
Arthroscopy of knee
Item
knee arthroscopy in past 12 months
boolean
C1304878 (UMLS CUI [1])
Arthroscopy Anticipated | Operative Surgical Procedures Anticipated
Item
anticipated arthroscopy or surgery in next 18 months
boolean
C0003904 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Hyaluronan Intra-Articular Injection | Hyalgan Intra-Articular Injection | Synvisc Intra-Articular Injection | Orthovisc Intra-Articular Injection | Glucocorticoids Injection | Kenalog Injection | Aristospan Injection | Depo-Medrol Injection | Knee injection Anticipated
Item
use of intra-articular injections of hyaluronan (e.g. hyalgan (tm), synvisc (tm), orthovisc (tm)) in past 6 months, or injections of glucocorticoids (e.g. kenalog (tm), aristospan (tm), depo-medrol (tm)) in past 3 months or anticipated knee injections during the study
boolean
C0020196 (UMLS CUI [1,1])
C0021488 (UMLS CUI [1,2])
C0598621 (UMLS CUI [2,1])
C0021488 (UMLS CUI [2,2])
C0723570 (UMLS CUI [3,1])
C0021488 (UMLS CUI [3,2])
C1311677 (UMLS CUI [4,1])
C0021488 (UMLS CUI [4,2])
C0017710 (UMLS CUI [5,1])
C1828121 (UMLS CUI [5,2])
C0699689 (UMLS CUI [6,1])
C1828121 (UMLS CUI [6,2])
C0718654 (UMLS CUI [7])
C0057476 (UMLS CUI [8,1])
C1828121 (UMLS CUI [8,2])
C0187946 (UMLS CUI [9,1])
C3840775 (UMLS CUI [9,2])
Glucosamine Dose Stable | Chondroitin Sulfates Dose Stable
Item
glucosamine or chondroitin sulfate are allowable if they are at a stable dose for past 3 months and will continue at that dose during the study
boolean
C0017718 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0008466 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Exclusion Criteria Additional
Item
other exclusion criteria apply-please ask the study doctor for details
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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