ID

14612

Description

A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00568295

Link

https://clinicaltrials.gov/show/NCT00568295

Keywords

Versions (1)
  1. 4/24/16 4/24/16 -
Uploaded on

April 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT00568295

English

Eligibility Osteoarthritis of the Knee NCT00568295

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months.
Description

Osteoarthritis of the knee: specification

Data type

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2]
C0002771
UMLS CUI [3]
C0003209
a history of osteoarthritis of the knee characterized by pain of at least a moderate intensity.
Description

Pain due to osteoarthritis of the knee

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0409959
demonstrated radiographic evidence of mild to moderate osteoarthritis based on the kellgren and lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.
Description

Kellgren and Lawrence radiographic entry criteria

Data type

boolean

Alias
UMLS CUI [1]
C3177117
subjects' physical ability was to be either american college of rheumatology (acr) function class i or ii
Description

American college of rheumatology (acr) function class

Data type

boolean

Alias
UMLS CUI [1]
C3273747
at the baseline visit, subjects must have reported a maximum pain intensity experienced over the previous 24 hours of at least moderate on a five-point scale of none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be enrolled in the study.
Description

Pain score

Data type

boolean

Alias
UMLS CUI [1]
C0582148
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
medical history, physical examinations, or radiographs suggestive of other types of arthritis, pseudogout, collagen vascular disease or fibromyalgia.
Description

Other types of arthritis, pseudogout, collagen vascular disease or fibromyalgia

Data type

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0033802
UMLS CUI [3]
C0262428
UMLS CUI [4]
C0016053
medical or psychiatric conditions that may influence absorption, metabolism, or excretion of the study medications or interfere with interpretation of adverse reactions to the study drug.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
history of allergy, sensitivity, contraindication or non-response to acetaminophen, rofecoxib, or drugs classified as nsaids including aspirin.
Description

Allergies, contraindications and non-response

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0000970
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0762662
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0003211
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0000970
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0762662
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0003211
UMLS CUI [7,1]
C3844724
UMLS CUI [7,2]
C0000970
UMLS CUI [8,1]
C3844724
UMLS CUI [8,2]
C0762662
UMLS CUI [9,1]
C3844724
UMLS CUI [9,2]
C0003211
use of concomitant medications that might interfere with study drug assessments, including intra-articular corticosteroids.
Description

Concomitant medications

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0304229
signs of active knee inflammation, morning stiffness of greater than 30 minutes duration.
Description

Knee inflammation and morning stiffness

Data type

boolean

Alias
UMLS CUI [1]
C0745545
UMLS CUI [2]
C0457086
rheumatoid factor quantitative value greater than or equal to 40 iu/ml or a westergren erythrocyte sedimentation rate greater than or equal to 40 mm/hour.
Description

Rheumatoid factor or westergren erythrocyte sedimentation rate

Data type

boolean

Alias
UMLS CUI [1]
C0201660
UMLS CUI [2]
C0200705
acr functional class iii or iv, or unable to walk without assistive devices.
Description

American College of Rheumatology Criteria

Data type

boolean

Alias
UMLS CUI [1]
C3273740
pregnancy, lactation, or expect to become pregnant within one month of study completion.
Description

Gynaecological status

Data type

boolean

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

Eligibility Osteoarthritis of the Knee NCT00568295

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Osteoarthritis of the knee: specification
Item
symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months.
boolean
C0409959 (UMLS CUI [1])
C0002771 (UMLS CUI [2])
C0003209 (UMLS CUI [3])
Pain due to osteoarthritis of the knee
Item
a history of osteoarthritis of the knee characterized by pain of at least a moderate intensity.
boolean
C0030193 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
Kellgren and Lawrence radiographic entry criteria
Item
demonstrated radiographic evidence of mild to moderate osteoarthritis based on the kellgren and lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.
boolean
C3177117 (UMLS CUI [1])
American college of rheumatology (acr) function class
Item
subjects' physical ability was to be either american college of rheumatology (acr) function class i or ii
boolean
C3273747 (UMLS CUI [1])
Pain score
Item
at the baseline visit, subjects must have reported a maximum pain intensity experienced over the previous 24 hours of at least moderate on a five-point scale of none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be enrolled in the study.
boolean
C0582148 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Other types of arthritis, pseudogout, collagen vascular disease or fibromyalgia
Item
medical history, physical examinations, or radiographs suggestive of other types of arthritis, pseudogout, collagen vascular disease or fibromyalgia.
boolean
C0003864 (UMLS CUI [1])
C0033802 (UMLS CUI [2])
C0262428 (UMLS CUI [3])
C0016053 (UMLS CUI [4])
Comorbidity
Item
medical or psychiatric conditions that may influence absorption, metabolism, or excretion of the study medications or interfere with interpretation of adverse reactions to the study drug.
boolean
C0009488 (UMLS CUI [1])
Allergies, contraindications and non-response
Item
history of allergy, sensitivity, contraindication or non-response to acetaminophen, rofecoxib, or drugs classified as nsaids including aspirin.
boolean
C0020517 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0762662 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0003211 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0000970 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0762662 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0003211 (UMLS CUI [6,2])
C3844724 (UMLS CUI [7,1])
C0000970 (UMLS CUI [7,2])
C3844724 (UMLS CUI [8,1])
C0762662 (UMLS CUI [8,2])
C3844724 (UMLS CUI [9,1])
C0003211 (UMLS CUI [9,2])
Concomitant medications
Item
use of concomitant medications that might interfere with study drug assessments, including intra-articular corticosteroids.
boolean
C2347852 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Knee inflammation and morning stiffness
Item
signs of active knee inflammation, morning stiffness of greater than 30 minutes duration.
boolean
C0745545 (UMLS CUI [1])
C0457086 (UMLS CUI [2])
Rheumatoid factor or westergren erythrocyte sedimentation rate
Item
rheumatoid factor quantitative value greater than or equal to 40 iu/ml or a westergren erythrocyte sedimentation rate greater than or equal to 40 mm/hour.
boolean
C0201660 (UMLS CUI [1])
C0200705 (UMLS CUI [2])
American College of Rheumatology Criteria
Item
acr functional class iii or iv, or unable to walk without assistive devices.
boolean
C3273740 (UMLS CUI [1])
Gynaecological status
Item
pregnancy, lactation, or expect to become pregnant within one month of study completion.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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