ID

31287

Beschrijving

Diacerein as Adjuvant to Diclofenac Sodium in Indian Patients of Osteoarthritis (OA) Knee; ODM derived from: https://clinicaltrials.gov/show/NCT01120015

Link

https://clinicaltrials.gov/show/NCT01120015

Trefwoorden

Versies (1)
  1. 08-08-18 08-08-18 -
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See clinicaltrials.gov

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8 augustus 2018

DOI

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Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT01120015

Engels

Eligibility Osteoarthritis NCT01120015

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary osteoarthritis patients recruited were between 35 to 60 years of age, with x-ray confirmed kellgren-lawrence grade13 ii or iii severity primary tibiofemoral oa, according to the american college of rheumatology criteria.
Beschrijving

Idiopathic osteoarthritis | Age | Idiopathic osteoarthritis Tibiofemoral Kellgren-Lawrence score X-ray

Datatype

boolean

Alias
UMLS CUI [1]
C0409952
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0409952
UMLS CUI [3,2]
C1269072
UMLS CUI [3,3]
C3177117
UMLS CUI [3,4]
C0034571
women of childbearing age had to provide evidence of adequate contraception prior to inclusion.
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
those patients were excluded from the present study who:
Beschrijving

Patients Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332196
were of age less than 35 years or more than 60 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
Beschrijving

Gastroduodenal disorder | Hepatic impairment | Renal Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C3874418
UMLS CUI [2]
C0948807
UMLS CUI [3]
C1565489
were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying oa of the hip of sufficient severity to interfere with the functional assessment of the knee
Beschrijving

Arthritis | Gout | Knee Injuries | HIP INJURY TRAUMA | SPINE INJURY TRAUMA | Osteoarthritis of hip | Interference Functional assessment Knee

Datatype

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0018099
UMLS CUI [3]
C0022744
UMLS CUI [4]
C0744931
UMLS CUI [5]
C0748916
UMLS CUI [6]
C0029410
UMLS CUI [7,1]
C0521102
UMLS CUI [7,2]
C0278372
UMLS CUI [7,3]
C0022742
had previous or ongoing treatment with oral sysdoa (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study
Beschrijving

Pharmacotherapy Oral Osteoarthritis | Glucosamine Sulfate | Chondroitin Sulfates | Diacetylrhein | Piascledine | Antidepressive Agents | Tranquilizing Agents | Antacids | Antibiotics | Cardiac lesion | Hypertensive disease | Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0029408
UMLS CUI [2]
C0017720
UMLS CUI [3]
C0008466
UMLS CUI [4]
C0057678
UMLS CUI [5]
C0071027
UMLS CUI [6]
C0003289
UMLS CUI [7]
C0040614
UMLS CUI [8]
C0003138
UMLS CUI [9]
C0003232
UMLS CUI [10]
C1391976
UMLS CUI [11]
C0020538
UMLS CUI [12]
C0032961
UMLS CUI [13]
C0032992
were having a known hypersensitivity to diclofenac sodium, to diacerein, to similar compounds, to the excipients or paracetamol, have history of painful knee conditions other than oa
Beschrijving

Hypersensitivity Diclofenac Sodium | Hypersensitivity Diacetylrhein | Hypersensitivity Compound Similar | Hypersensitivity Acetaminophen Excipient | Knee pain Except Osteoarthritis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0700583
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0057678
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C2348205
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0000970
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0231749
UMLS CUI [5,2]
C0332300
UMLS CUI [5,3]
C0029408
have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin< 10.0 g/ dl or haematocrit < 30%).
Beschrijving

Diarrhea persistent | Laxative usage | Gastrointestinal Diseases Severe | Obesity, Morbid | Parenchymal Organ Disease Severe | Anemia | Hemoglobin measurement | Hematocrit level

Datatype

boolean

Alias
UMLS CUI [1]
C0743188
UMLS CUI [2]
C0240170
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0028756
UMLS CUI [5,1]
C4277702
UMLS CUI [5,2]
C0178784
UMLS CUI [5,3]
C0012634
UMLS CUI [5,4]
C0205082
UMLS CUI [6]
C0002871
UMLS CUI [7]
C0518015
UMLS CUI [8]
C0518014
patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.
Beschrijving

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intramuscular injection | Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Injection of soft tissue | Joint lavage | Arthroscopy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0021492
UMLS CUI [3]
C2064783
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0185357
UMLS CUI [5,1]
C0022417
UMLS CUI [5,2]
C0022100
UMLS CUI [6]
C0003904
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Similar models

Eligibility Osteoarthritis NCT01120015

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Idiopathic osteoarthritis | Age | Idiopathic osteoarthritis Tibiofemoral Kellgren-Lawrence score X-ray
Item
primary osteoarthritis patients recruited were between 35 to 60 years of age, with x-ray confirmed kellgren-lawrence grade13 ii or iii severity primary tibiofemoral oa, according to the american college of rheumatology criteria.
boolean
C0409952 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0409952 (UMLS CUI [3,1])
C1269072 (UMLS CUI [3,2])
C3177117 (UMLS CUI [3,3])
C0034571 (UMLS CUI [3,4])
Childbearing Potential Contraceptive methods
Item
women of childbearing age had to provide evidence of adequate contraception prior to inclusion.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Patients Excluded
Item
those patients were excluded from the present study who:
boolean
C0030705 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Age
Item
were of age less than 35 years or more than 60 years
boolean
C0001779 (UMLS CUI [1])
Gastroduodenal disorder | Hepatic impairment | Renal Insufficiency
Item
presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
boolean
C3874418 (UMLS CUI [1])
C0948807 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
Arthritis | Gout | Knee Injuries | HIP INJURY TRAUMA | SPINE INJURY TRAUMA | Osteoarthritis of hip | Interference Functional assessment Knee
Item
were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying oa of the hip of sufficient severity to interfere with the functional assessment of the knee
boolean
C0003864 (UMLS CUI [1])
C0018099 (UMLS CUI [2])
C0022744 (UMLS CUI [3])
C0744931 (UMLS CUI [4])
C0748916 (UMLS CUI [5])
C0029410 (UMLS CUI [6])
C0521102 (UMLS CUI [7,1])
C0278372 (UMLS CUI [7,2])
C0022742 (UMLS CUI [7,3])
Pharmacotherapy Oral Osteoarthritis | Glucosamine Sulfate | Chondroitin Sulfates | Diacetylrhein | Piascledine | Antidepressive Agents | Tranquilizing Agents | Antacids | Antibiotics | Cardiac lesion | Hypertensive disease | Pregnancy | Pregnancy, Planned
Item
had previous or ongoing treatment with oral sysdoa (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study
boolean
C0013216 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
C0017720 (UMLS CUI [2])
C0008466 (UMLS CUI [3])
C0057678 (UMLS CUI [4])
C0071027 (UMLS CUI [5])
C0003289 (UMLS CUI [6])
C0040614 (UMLS CUI [7])
C0003138 (UMLS CUI [8])
C0003232 (UMLS CUI [9])
C1391976 (UMLS CUI [10])
C0020538 (UMLS CUI [11])
C0032961 (UMLS CUI [12])
C0032992 (UMLS CUI [13])
Hypersensitivity Diclofenac Sodium | Hypersensitivity Diacetylrhein | Hypersensitivity Compound Similar | Hypersensitivity Acetaminophen Excipient | Knee pain Except Osteoarthritis
Item
were having a known hypersensitivity to diclofenac sodium, to diacerein, to similar compounds, to the excipients or paracetamol, have history of painful knee conditions other than oa
boolean
C0020517 (UMLS CUI [1,1])
C0700583 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0057678 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0000970 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0231749 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C0029408 (UMLS CUI [5,3])
Diarrhea persistent | Laxative usage | Gastrointestinal Diseases Severe | Obesity, Morbid | Parenchymal Organ Disease Severe | Anemia | Hemoglobin measurement | Hematocrit level
Item
have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin< 10.0 g/ dl or haematocrit < 30%).
boolean
C0743188 (UMLS CUI [1])
C0240170 (UMLS CUI [2])
C0017178 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0028756 (UMLS CUI [4])
C4277702 (UMLS CUI [5,1])
C0178784 (UMLS CUI [5,2])
C0012634 (UMLS CUI [5,3])
C0205082 (UMLS CUI [5,4])
C0002871 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C0518014 (UMLS CUI [8])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intramuscular injection | Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Injection of soft tissue | Joint lavage | Arthroscopy
Item
patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0021492 (UMLS CUI [2,2])
C2064783 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0185357 (UMLS CUI [4,2])
C0022417 (UMLS CUI [5,1])
C0022100 (UMLS CUI [5,2])
C0003904 (UMLS CUI [6])
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