ID

18712

Beschrijving

A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00411164

Link

https://clinicaltrials.gov/show/NCT00411164

Trefwoorden

Versies (1)
  1. 17-11-16 17-11-16 -
Geüploaded op

17 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Hip NCT00411164

Engels

Eligibility Osteoarthritis, Hip NCT00411164

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must have a negative pregnancy test at screening and be postmenopausal for at least 1 year or surgically sterile or practicing a medically recognized contraceptive program
Beschrijving

Pregnancy test negative | Postmenopausal state | Female Sterilization | Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0700589
patient has been diagnosed with functional class i-iii osteoarthritis of the knee or hip
Beschrijving

Osteoarthritis, Knee | Osteoarthritis of hip | Kellgren-Lawrence score

Datatype

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2]
C0029410
UMLS CUI [3]
C3177117
patient has required treatment of target joint pain within the 90 days prior to study start and met at least one of the following: was unable to consistently control target joint pain with non-opioid pain reliever, unable to treat target joint pain with non-opioid pain reliever because treatment was contraindicated per investigator judgement, or had received an opioid(single or combination product) for treatment of target joint pain, with the equivalent of less than or equal to 40 mg/day of oral morphine sulfate, inclusive of breakthrough pain medication
Beschrijving

Therapeutic procedure Pain Target Joint | Pain control Target Joint Unable | Analgesics, Non-Narcotic | Medical contraindication Therapeutic procedure | Opioid Single | Opioids Combined | Morphine Sulfate Oral | Breakthrough Pain Pharmaceutical Preparations

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0022417
UMLS CUI [2,1]
C0002766
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0022417
UMLS CUI [2,4]
C1299582
UMLS CUI [3]
C0242937
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0087111
UMLS CUI [5,1]
C0242402
UMLS CUI [5,2]
C0205171
UMLS CUI [6,1]
C0242402
UMLS CUI [6,2]
C0205195
UMLS CUI [7,1]
C0066814
UMLS CUI [7,2]
C1527415
UMLS CUI [8,1]
C1135120
UMLS CUI [8,2]
C0013227
patient has reported a target joint pain score of at least 5 (11-point likert scale) at baseline
Beschrijving

Pain Target Joint | Pain Rating Likert Scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022417
UMLS CUI [2]
C3899970
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient for whom hydromorphone was contraindicated because of a documented history of an allergic reaction (hives, rash, etc) or a clinically significant intolerance to hydromorphone or other opioids
Beschrijving

Medical contraindication Hydromorphone | Allergic Reaction Hydromorphone | Urticaria | Exanthema | intolerance Clinical Significance Hydromorphone | intolerance Clinical Significance Opioids

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0012306
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0012306
UMLS CUI [3]
C0042109
UMLS CUI [4]
C0015230
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C2826293
UMLS CUI [5,3]
C0012306
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C2826293
UMLS CUI [6,3]
C0242402
patient requiring treatment with monoamine oxidase inhibitors, or receiving systemic chemotherapy or had an active malignancy of any type or had clinically significant abnormalities in clinical chemistry, hematology or urinalysis, or had a documented history of gout, pseudogout, paget's disease, fibromyalgia
Beschrijving

Monoamine Oxidase Inhibitors Patient need for | Systemic Chemotherapy | Malignant Neoplasms | Clinical Chemistry Abnormality Clinical Significance | Hematology Abnormality Clinical Significance | Urinalysis Abnormality Clinical Significance | Gout | Pseudogout | Paget's Disease | Fibromyalgia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026457
UMLS CUI [1,2]
C0686904
UMLS CUI [2]
C1883256
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C2347783
UMLS CUI [4,2]
C1704258
UMLS CUI [4,3]
C2826293
UMLS CUI [5,1]
C0200627
UMLS CUI [5,2]
C1704258
UMLS CUI [5,3]
C2826293
UMLS CUI [6,1]
C0042014
UMLS CUI [6,2]
C1704258
UMLS CUI [6,3]
C2826293
UMLS CUI [7]
C0018099
UMLS CUI [8]
C0033802
UMLS CUI [9]
C1368019
UMLS CUI [10]
C0016053
uncontrolled inflammatory arthritis or nsaid-dependent inflammatory arthritis or any chronic pain syndrome that could interfere with the assessment of pain and/or other symptoms of osteoarthritis
Beschrijving

Arthritis Uncontrolled | Arthritis Non-Steroidal Anti-Inflammatory Agents Dependent | Chronic pain syndrome Interferes with Pain Measurement | Osteoarthritis Symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0003864
UMLS CUI [2,2]
C0003211
UMLS CUI [2,3]
C0851827
UMLS CUI [3,1]
C1298685
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0030198
UMLS CUI [4,1]
C0029408
UMLS CUI [4,2]
C1457887
patient who is pregnant and/or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient with a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse, or unable to discontinue all formulations of prior pain medications (opioid and/or non-opioid) during the washout period of the study
Beschrijving

Drug abuse | Drug Dependence | Narcotic Analgesics Abuse | Narcotic Analgesics Dependence | Narcotic Analgesics MISUSE | Analgesics Formulations Discontinue Unable | Opioids | Analgesics, Non-Narcotic

Datatype

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C1510472
UMLS CUI [3,1]
C0027409
UMLS CUI [3,2]
C1546935
UMLS CUI [4,1]
C0027409
UMLS CUI [4,2]
C0439857
UMLS CUI [5,1]
C0027409
UMLS CUI [5,2]
C0549649
UMLS CUI [6,1]
C0002771
UMLS CUI [6,2]
C0013058
UMLS CUI [6,3]
C1444662
UMLS CUI [6,4]
C1299582
UMLS CUI [7]
C0242402
UMLS CUI [8]
C0242937
patient who had a documented history of a medical condition, which, in the investigator's opinion, could compromise the patient's ability to swallow, absorb, metabolize, or excrete study drug, including (but not limited to) intractable nausea and/or vomiting, and/or severe gastrointestinal narrowing
Beschrijving

Medical condition Able to swallow Investigational Drug Limited | Medical condition Drug absorption Limited | Medical condition Metabolic Process Investigational Drug Limited | Medical condition Excretion Investigational Drug Limited | NAUSEA INTRACTABLE | Intractable vomiting | Narrowing gastrointestinal Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C0439801
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0678745
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1524026
UMLS CUI [3,3]
C0013230
UMLS CUI [3,4]
C0439801
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0221102
UMLS CUI [4,3]
C0013230
UMLS CUI [4,4]
C0439801
UMLS CUI [5]
C0746781
UMLS CUI [6]
C0750323
UMLS CUI [7,1]
C0332463
UMLS CUI [7,2]
C0521362
UMLS CUI [7,3]
C0205082
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Similar models

Eligibility Osteoarthritis, Hip NCT00411164

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Pregnancy test negative | Postmenopausal state | Female Sterilization | Contraceptive methods
Item
patient must have a negative pregnancy test at screening and be postmenopausal for at least 1 year or surgically sterile or practicing a medically recognized contraceptive program
boolean
C0427780 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Osteoarthritis, Knee | Osteoarthritis of hip | Kellgren-Lawrence score
Item
patient has been diagnosed with functional class i-iii osteoarthritis of the knee or hip
boolean
C0409959 (UMLS CUI [1])
C0029410 (UMLS CUI [2])
C3177117 (UMLS CUI [3])
Therapeutic procedure Pain Target Joint | Pain control Target Joint Unable | Analgesics, Non-Narcotic | Medical contraindication Therapeutic procedure | Opioid Single | Opioids Combined | Morphine Sulfate Oral | Breakthrough Pain Pharmaceutical Preparations
Item
patient has required treatment of target joint pain within the 90 days prior to study start and met at least one of the following: was unable to consistently control target joint pain with non-opioid pain reliever, unable to treat target joint pain with non-opioid pain reliever because treatment was contraindicated per investigator judgement, or had received an opioid(single or combination product) for treatment of target joint pain, with the equivalent of less than or equal to 40 mg/day of oral morphine sulfate, inclusive of breakthrough pain medication
boolean
C0087111 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0022417 (UMLS CUI [1,4])
C0002766 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0242937 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0242402 (UMLS CUI [5,1])
C0205171 (UMLS CUI [5,2])
C0242402 (UMLS CUI [6,1])
C0205195 (UMLS CUI [6,2])
C0066814 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C1135120 (UMLS CUI [8,1])
C0013227 (UMLS CUI [8,2])
Pain Target Joint | Pain Rating Likert Scale
Item
patient has reported a target joint pain score of at least 5 (11-point likert scale) at baseline
boolean
C0030193 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C3899970 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Hydromorphone | Allergic Reaction Hydromorphone | Urticaria | Exanthema | intolerance Clinical Significance Hydromorphone | intolerance Clinical Significance Opioids
Item
patient for whom hydromorphone was contraindicated because of a documented history of an allergic reaction (hives, rash, etc) or a clinically significant intolerance to hydromorphone or other opioids
boolean
C1301624 (UMLS CUI [1,1])
C0012306 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0012306 (UMLS CUI [2,2])
C0042109 (UMLS CUI [3])
C0015230 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0012306 (UMLS CUI [5,3])
C1744706 (UMLS CUI [6,1])
C2826293 (UMLS CUI [6,2])
C0242402 (UMLS CUI [6,3])
Monoamine Oxidase Inhibitors Patient need for | Systemic Chemotherapy | Malignant Neoplasms | Clinical Chemistry Abnormality Clinical Significance | Hematology Abnormality Clinical Significance | Urinalysis Abnormality Clinical Significance | Gout | Pseudogout | Paget's Disease | Fibromyalgia
Item
patient requiring treatment with monoamine oxidase inhibitors, or receiving systemic chemotherapy or had an active malignancy of any type or had clinically significant abnormalities in clinical chemistry, hematology or urinalysis, or had a documented history of gout, pseudogout, paget's disease, fibromyalgia
boolean
C0026457 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C1883256 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C2347783 (UMLS CUI [4,1])
C1704258 (UMLS CUI [4,2])
C2826293 (UMLS CUI [4,3])
C0200627 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
C2826293 (UMLS CUI [5,3])
C0042014 (UMLS CUI [6,1])
C1704258 (UMLS CUI [6,2])
C2826293 (UMLS CUI [6,3])
C0018099 (UMLS CUI [7])
C0033802 (UMLS CUI [8])
C1368019 (UMLS CUI [9])
C0016053 (UMLS CUI [10])
Arthritis Uncontrolled | Arthritis Non-Steroidal Anti-Inflammatory Agents Dependent | Chronic pain syndrome Interferes with Pain Measurement | Osteoarthritis Symptoms
Item
uncontrolled inflammatory arthritis or nsaid-dependent inflammatory arthritis or any chronic pain syndrome that could interfere with the assessment of pain and/or other symptoms of osteoarthritis
boolean
C0003864 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0003864 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0851827 (UMLS CUI [2,3])
C1298685 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0030198 (UMLS CUI [3,3])
C0029408 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
patient who is pregnant and/or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Drug abuse | Drug Dependence | Narcotic Analgesics Abuse | Narcotic Analgesics Dependence | Narcotic Analgesics MISUSE | Analgesics Formulations Discontinue Unable | Opioids | Analgesics, Non-Narcotic
Item
patient with a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse, or unable to discontinue all formulations of prior pain medications (opioid and/or non-opioid) during the washout period of the study
boolean
C0013146 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0027409 (UMLS CUI [3,1])
C1546935 (UMLS CUI [3,2])
C0027409 (UMLS CUI [4,1])
C0439857 (UMLS CUI [4,2])
C0027409 (UMLS CUI [5,1])
C0549649 (UMLS CUI [5,2])
C0002771 (UMLS CUI [6,1])
C0013058 (UMLS CUI [6,2])
C1444662 (UMLS CUI [6,3])
C1299582 (UMLS CUI [6,4])
C0242402 (UMLS CUI [7])
C0242937 (UMLS CUI [8])
Medical condition Able to swallow Investigational Drug Limited | Medical condition Drug absorption Limited | Medical condition Metabolic Process Investigational Drug Limited | Medical condition Excretion Investigational Drug Limited | NAUSEA INTRACTABLE | Intractable vomiting | Narrowing gastrointestinal Severe
Item
patient who had a documented history of a medical condition, which, in the investigator's opinion, could compromise the patient's ability to swallow, absorb, metabolize, or excrete study drug, including (but not limited to) intractable nausea and/or vomiting, and/or severe gastrointestinal narrowing
boolean
C3843040 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0678745 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1524026 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0439801 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0221102 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C0439801 (UMLS CUI [4,4])
C0746781 (UMLS CUI [5])
C0750323 (UMLS CUI [6])
C0332463 (UMLS CUI [7,1])
C0521362 (UMLS CUI [7,2])
C0205082 (UMLS CUI [7,3])
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