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ID

18712

Description

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

Keywords

Versions (1)
  1. 11/17/16 11/17/16 -
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November 17, 2016

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Creative Commons BY 4.0
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    Eligibility Osteoarthritis, Hip NCT00411164

    English

    Eligibility Osteoarthritis, Hip NCT00411164

    1 forms  
    Inclusion Criteria
    Description

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    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
    Description

    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

    Data type

    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
    Description

    Pain Target Joint | Pain Rating Likert Scale

    Data type

    boolean

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

    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
    Description

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

    Data type

    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
    Description

    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

    Data type

    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
    Description

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

    Data type

    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
    Description

    Pregnancy | Breast Feeding

    Data type

    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
    Description

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

    Data type

    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
    Description

    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

    Data type

    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 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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