ID

15766

Description

A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02311881

Link

https://clinicaltrials.gov/show/NCT02311881

Keywords

Versions (1)
  1. 6/12/16 6/12/16 -
Uploaded on

June 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Pain NCT02311881

English

Eligibility Pain NCT02311881

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Pain NCT02311881
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female participants between 40 and 80 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of moderate to moderately-severe osteoarthritis (oa) of either the knee or hip with respect to the following:
Description

Osteoarthritis, Knee Moderate | Osteoarthritis, Knee Moderately severe pain | Osteoarthritis of hip Moderate | Osteoarthritis of hip Moderately severe pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C3843203
UMLS CUI [3,1]
C0029410
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C0029410
UMLS CUI [4,2]
C3843203
pain in one knee/hip over 3 months immediately before screening visit
Description

Knee pain | Hip pain

Data type

boolean

Alias
UMLS CUI [1]
C0231749
UMLS CUI [2]
C0019559
use of non steroidal anti-inflammatory drugs (nsaids), acetaminophen (paracetamol) or any other analgesic for 3 or more days per week for at least 3 months prior to screening visit
Description

Anti-Inflammatory Agents, Non-Steroidal | Acetaminophen | Analgesics

Data type

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0000970
UMLS CUI [3]
C0002771
clinical diagnosis of osteoarthritis of knee/hip for minimum 6 month duration prior to screening visit
Description

Prior diagnosis Osteoarthritis, Knee | Prior diagnosis Osteoarthritis of hip

Data type

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0409959
UMLS CUI [2,1]
C0332132
UMLS CUI [2,2]
C0029410
therapeutic benefit with acetaminophen use with a score of ≥ 1 on 5-point categorical scale
Description

Acetaminophen Benefit Therapeutic | Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C0302350
UMLS CUI [2]
C0449820
radiological evidence of ≥ grade 2 osteoarthritis according to kellgren-lawrence radiographic criteria
Description

Degenerative polyarthritis | Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2]
C3177117
increased womac pain subscale score of at least 20 % following untreated run-in period
Description

Western Ontario and McMaster Universities osteoarthritis index | Run-in Period untreated

Data type

boolean

Alias
UMLS CUI [1]
C3472647
UMLS CUI [2,1]
C3274438
UMLS CUI [2,2]
C0332155
moderate to moderately-severe self-reported pain on a 5-point categorical scale following untreated run-in period
Description

Moderate pain | Moderately severe pain | Run-in Period untreated

Data type

boolean

Alias
UMLS CUI [1]
C0278139
UMLS CUI [2]
C3843203
UMLS CUI [3,1]
C3274438
UMLS CUI [3,2]
C0332155
historical self-reported positive therapeutic benefit with paracetamol use for osteoarthritis pain relief
Description

Acetaminophen Benefit Therapeutic Positive | Degenerative polyarthritis Pain relief

Data type

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C0302350
UMLS CUI [1,4]
C1446409
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C0451615
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of surgery or major trauma to the study joint
Description

Operative Surgical Procedures Study Joint | Major injury Study Joint

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0022417
UMLS CUI [2,1]
C0332677
UMLS CUI [2,2]
C0008972
UMLS CUI [2,3]
C0022417
clinically significant signs or symptoms of inflammation upon completion of run-in period
Description

Sign or Symptom Inflammation | Run-in Period Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0021368
UMLS CUI [2,1]
C3274438
UMLS CUI [2,2]
C0205197
required ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments know to interfere with pain perception
Description

Indication Analgesic therapy Continuous | Anticoagulants | Psychotropic Drugs | Aspirin | Hypolipidemic Agents | Hydroxymethylglutaryl-CoA Reductase Inhibitors | Therapeutic procedure Interferes with Pain Perception

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0412784
UMLS CUI [1,3]
C0549178
UMLS CUI [2]
C0003280
UMLS CUI [3]
C0033978
UMLS CUI [4]
C0004057
UMLS CUI [5]
C0086440
UMLS CUI [6]
C0360714
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C3714605
history of hepatic or renal or liver or biliary disease or gastrointestinal surgery
Description

Liver diseases | Kidney Diseases | Biliary System Disorder | Gastrointestinal Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C3275124
UMLS CUI [5]
C0524722
participants with alanine aminotransferase (alt) >2 times upper limit normal (2xuln) and bilirubin > 1.5 times upper limit normal (1.5xuln) (however, if direct bilirubin is <35% and fractioned, isolated bilirubin >1.5xuln is acceptable)
Description

Alanine aminotransferase measurement | Serum total bilirubin measurement | Bilirubin, direct measurement | Bilirubin Fractionated | Bilirubin Isolated

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201916
UMLS CUI [4,1]
C0005437
UMLS CUI [4,2]
C1979893
UMLS CUI [5,1]
C0005437
UMLS CUI [5,2]
C0205409
other arthritis type, fibromyalgia or collagen vascular disease or secondary oa of study joint or chronic pain condition
Description

Arthritis Other | Fibromyalgia | Collagen-vascular disease | Secondary osteoarthritis Study Joint | Chronic pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0016053
UMLS CUI [3]
C0262428
UMLS CUI [4,1]
C2732281
UMLS CUI [4,2]
C0008972
UMLS CUI [4,3]
C0022417
UMLS CUI [5]
C0150055
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Similar models

Eligibility Pain NCT02311881

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Pain NCT02311881
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female participants between 40 and 80 years of age
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis, Knee Moderate | Osteoarthritis, Knee Moderately severe pain | Osteoarthritis of hip Moderate | Osteoarthritis of hip Moderately severe pain
Item
diagnosis of moderate to moderately-severe osteoarthritis (oa) of either the knee or hip with respect to the following:
boolean
C0409959 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0409959 (UMLS CUI [2,1])
C3843203 (UMLS CUI [2,2])
C0029410 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0029410 (UMLS CUI [4,1])
C3843203 (UMLS CUI [4,2])
Knee pain | Hip pain
Item
pain in one knee/hip over 3 months immediately before screening visit
boolean
C0231749 (UMLS CUI [1])
C0019559 (UMLS CUI [2])
Anti-Inflammatory Agents, Non-Steroidal | Acetaminophen | Analgesics
Item
use of non steroidal anti-inflammatory drugs (nsaids), acetaminophen (paracetamol) or any other analgesic for 3 or more days per week for at least 3 months prior to screening visit
boolean
C0003211 (UMLS CUI [1])
C0000970 (UMLS CUI [2])
C0002771 (UMLS CUI [3])
Prior diagnosis Osteoarthritis, Knee | Prior diagnosis Osteoarthritis of hip
Item
clinical diagnosis of osteoarthritis of knee/hip for minimum 6 month duration prior to screening visit
boolean
C0332132 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
C0332132 (UMLS CUI [2,1])
C0029410 (UMLS CUI [2,2])
Acetaminophen Benefit Therapeutic | Score
Item
therapeutic benefit with acetaminophen use with a score of ≥ 1 on 5-point categorical scale
boolean
C0000970 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C0449820 (UMLS CUI [2])
Degenerative polyarthritis | Kellgren-Lawrence score
Item
radiological evidence of ≥ grade 2 osteoarthritis according to kellgren-lawrence radiographic criteria
boolean
C0029408 (UMLS CUI [1])
C3177117 (UMLS CUI [2])
Western Ontario and McMaster Universities osteoarthritis index | Run-in Period untreated
Item
increased womac pain subscale score of at least 20 % following untreated run-in period
boolean
C3472647 (UMLS CUI [1])
C3274438 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Moderate pain | Moderately severe pain | Run-in Period untreated
Item
moderate to moderately-severe self-reported pain on a 5-point categorical scale following untreated run-in period
boolean
C0278139 (UMLS CUI [1])
C3843203 (UMLS CUI [2])
C3274438 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Acetaminophen Benefit Therapeutic Positive | Degenerative polyarthritis Pain relief
Item
historical self-reported positive therapeutic benefit with paracetamol use for osteoarthritis pain relief
boolean
C0000970 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C1446409 (UMLS CUI [1,4])
C0029408 (UMLS CUI [2,1])
C0451615 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedures Study Joint | Major injury Study Joint
Item
history of surgery or major trauma to the study joint
boolean
C0543467 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C0332677 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
Sign or Symptom Inflammation | Run-in Period Completion
Item
clinically significant signs or symptoms of inflammation upon completion of run-in period
boolean
C3540840 (UMLS CUI [1,1])
C0021368 (UMLS CUI [1,2])
C3274438 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Indication Analgesic therapy Continuous | Anticoagulants | Psychotropic Drugs | Aspirin | Hypolipidemic Agents | Hydroxymethylglutaryl-CoA Reductase Inhibitors | Therapeutic procedure Interferes with Pain Perception
Item
required ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments know to interfere with pain perception
boolean
C3146298 (UMLS CUI [1,1])
C0412784 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0003280 (UMLS CUI [2])
C0033978 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
C0086440 (UMLS CUI [5])
C0360714 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C3714605 (UMLS CUI [7,3])
Liver diseases | Kidney Diseases | Biliary System Disorder | Gastrointestinal Surgical Procedure
Item
history of hepatic or renal or liver or biliary disease or gastrointestinal surgery
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C3275124 (UMLS CUI [4])
C0524722 (UMLS CUI [5])
Alanine aminotransferase measurement | Serum total bilirubin measurement | Bilirubin, direct measurement | Bilirubin Fractionated | Bilirubin Isolated
Item
participants with alanine aminotransferase (alt) >2 times upper limit normal (2xuln) and bilirubin > 1.5 times upper limit normal (1.5xuln) (however, if direct bilirubin is <35% and fractioned, isolated bilirubin >1.5xuln is acceptable)
boolean
C0201836 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201916 (UMLS CUI [3])
C0005437 (UMLS CUI [4,1])
C1979893 (UMLS CUI [4,2])
C0005437 (UMLS CUI [5,1])
C0205409 (UMLS CUI [5,2])
Arthritis Other | Fibromyalgia | Collagen-vascular disease | Secondary osteoarthritis Study Joint | Chronic pain
Item
other arthritis type, fibromyalgia or collagen vascular disease or secondary oa of study joint or chronic pain condition
boolean
C0003864 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0016053 (UMLS CUI [2])
C0262428 (UMLS CUI [3])
C2732281 (UMLS CUI [4,1])
C0008972 (UMLS CUI [4,2])
C0022417 (UMLS CUI [4,3])
C0150055 (UMLS CUI [5])
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