ID

31300

Beschreibung

Efficacy and Safety Study Evaluating ADL5859 and ADL5747 in Participants With Pain Due to Osteoarthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00979953

Link

https://clinicaltrials.gov/show/NCT00979953

Stichworte

Versionen (1)
  1. 10.08.18 10.08.18 -
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See clinicaltrials.gov

Hochgeladen am

10. August 2018

DOI

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Lizenz

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Eligibility Osteoarthritis of the Knee NCT00979953

Englisch

Eligibility Osteoarthritis of the Knee NCT00979953

1 Formulare  
Criteria
Beschreibung

Criteria

a man or woman between 18 and 75 years of age, inclusive
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
for women of childbearing potential, be using an insertable, injectable, transdermal, or combination oral contraceptive deemed highly effective by the united states food and drug administration from the first dose of study medication through the end of the study and have negative findings on pregnancy tests performed at screening and randomization (women who are surgically sterile [for example, hysterectomy, tubal ligation] or postmenopausal [if ≥55 years old, no menses for at least 2 years; if <55 years old, follicle-stimulating hormone concentrations within the postmenopausal range of >40 milli-international units per milliliter (miu/ml) and 17 β-estradiol levels of <37 picograms per milliliter (pg/ml)] are also eligible to participate)
Beschreibung

Childbearing Potential Contraceptive methods | Insertion of a contraceptive implant | Injectable contraception | Transdermal contraception | Oral Contraceptives Combination | Childbearing Potential Pregnancy test negative | Female Sterilization | Hysterectomy | Tubal Ligation | Postmenopausal state | Follicle stimulating hormone measurement | Estradiol measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C1657105
UMLS CUI [3]
C1262153
UMLS CUI [4]
C1168146
UMLS CUI [5,1]
C0009905
UMLS CUI [5,2]
C0205195
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0427780
UMLS CUI [7]
C0015787
UMLS CUI [8]
C0020699
UMLS CUI [9]
C0520483
UMLS CUI [10]
C0232970
UMLS CUI [11]
C0202022
UMLS CUI [12]
C0337434
for male participants, be surgically sterile or agree to use an appropriate method of contraception (that is, use a barrier method in conjunction with spermicide or have a sexual partner who is surgically sterile, postmenopausal, or using an insertable, injectable, transdermal, or combination oral contraceptive deemed highly effective by the united states food and drug administration) from the first dose of study medication through the end of the study
Beschreibung

Gender Male sterilization | Gender Contraceptive methods | Contraception, Barrier | Spermatocidal Agents | Partner Female Sterilization | Partner Postmenopausal state | Partner Insertion of a contraceptive implant | Partner Injectable contraception | Partner Transdermal contraception | Partner Oral Contraceptives Combination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0024559
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0004764
UMLS CUI [4]
C0037862
UMLS CUI [5,1]
C0682323
UMLS CUI [5,2]
C0015787
UMLS CUI [6,1]
C0682323
UMLS CUI [6,2]
C0232970
UMLS CUI [7,1]
C0682323
UMLS CUI [7,2]
C1657105
UMLS CUI [8,1]
C0682323
UMLS CUI [8,2]
C1262153
UMLS CUI [9,1]
C0682323
UMLS CUI [9,2]
C1168146
UMLS CUI [10,1]
C0682323
UMLS CUI [10,2]
C0009905
UMLS CUI [10,3]
C0205195
have a body weight between 45 and 150 kilograms (kg), inclusive
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
have had pain in the index knee for at least the past 6 months
Beschreibung

Pain Index Knee Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022742
UMLS CUI [1,4]
C0449238
meet the following criteria for osteoarthritis of the knee established by the american college of rheumatology (radiographs must have been taken within the last year; if none is available, a radiograph must be taken and the diagnostic criteria must be confirmed before the participant is enrolled in the study): have index knee pain plus at least 1 moderate or definite osteophyte on radiographs. must also have at least 1 of the following: be more than 50 years old, have morning stiffness for less than 30 minutes, or have crepitus on active motion
Beschreibung

Criteria Fulfill Knee Osteoarthritis | Diagnostic radiologic examination | Pain Index Knee | Osteophyte Moderate Quantity Radiograph | Osteophyte Definite Quantity Radiograph | Age | Morning stiffness Duration | Crepitus During Active motion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0409959
UMLS CUI [2]
C0043299
UMLS CUI [3,1]
C0030193
UMLS CUI [3,2]
C2986546
UMLS CUI [3,3]
C0022742
UMLS CUI [4,1]
C1956089
UMLS CUI [4,2]
C0205081
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C1306645
UMLS CUI [5,1]
C1956089
UMLS CUI [5,2]
C0439544
UMLS CUI [5,3]
C1265611
UMLS CUI [5,4]
C1306645
UMLS CUI [6]
C0001779
UMLS CUI [7,1]
C0457086
UMLS CUI [7,2]
C0449238
UMLS CUI [8,1]
C0231592
UMLS CUI [8,2]
C0347984
UMLS CUI [8,3]
C0231481
have an average weekly pain score of at least 4.00 on the numeric pain rating scale (nprs) for the index knee during the baseline week before randomization (to be eligible for randomization, participants must report their nprs score via the interactive voice-response system (ivrs) for at least 4 of the 7 days immediately before randomization, with the first score being recorded on day -6)
Beschreibung

Pain Index Knee Numeric Pain Scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022742
UMLS CUI [1,4]
C1518471
if receiving nonselective or selective cyclooxygenase (cox) inhibitors, have a stable daily dose regimen for at least 4 weeks before screening; if receiving nonselective or selective cox inhibitors on an as needed basis, have discontinued use by day -14; if receiving angiotensin-converting enzyme (ace) inhibitors, have a stable dose regimen for at least 4 weeks before screening
Beschreibung

Cyclooxygenase Inhibitors Dose Stable | Angiotensin-Converting Enzyme Inhibitors Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085387
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
have undergone arthroscopy on the index knee within 6 months before study entry
Beschreibung

Arthroscopy Index Knee

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003904
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022742
have other severe pain that, in the opinion of the investigator, may impair the assessment of the pain due to osteoarthritis
Beschreibung

Severe pain Other | Interference Pain Due to Osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278140
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0030193
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0029408
have a history of hypersensitivity or intolerance to opioids (including tramadol and tapentadol)
Beschreibung

Hypersensitivity Opioids | Intolerance to Opioids | Allergy to tramadol | Intolerance to Tramadol | Hypersensitivity Tapentadol | Intolerance to Tapentadol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0242402
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0242402
UMLS CUI [3]
C3472517
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0040610
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C2001271
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C2001271
have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, hematologic, cardiovascular, metabolic, gastrointestinal, neurologic, psychiatric, or another condition that would preclude participation in the study or affect the outcome of the study
Beschreibung

Kidney Disease | Liver disease | Hematological Disease | Cardiovascular Disease | Metabolic Disease | Gastrointestinal Disease | Nervous system disorder | Mental disorder | Condition Study Subject Participation Status Excluded | Condition Affecting Research results

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0025517
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0004936
UMLS CUI [9,1]
C0348080
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C0332196
UMLS CUI [10,1]
C0348080
UMLS CUI [10,2]
C0392760
UMLS CUI [10,3]
C0683954
have taken oral or intramuscular corticosteroids within 30 days before study entry (inhaled or topical corticosteroids are permitted)
Beschreibung

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Inhalation allowed | Topical corticosteroids allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1556154
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205535
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0304604
UMLS CUI [4,2]
C0683607
have received intra-articular injections of corticosteroids into the index joint within 12 weeks before screening
Beschreibung

Intraarticular injection of corticosteroids Index Joint

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2064783
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022417
have received intra-articular injections of hyaluronic acid into the index joint within 24 weeks before screening
Beschreibung

Intra-Articular Injections Hyaluronic Acid Index Joint

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021488
UMLS CUI [1,2]
C0020196
UMLS CUI [1,3]
C2986546
UMLS CUI [1,4]
C0022417
currently taking medications other than nonsteroidal anti-inflammatory drugs prescribed for chronic pain (such as duloxetine or pregabalin)
Beschreibung

Pharmaceutical Preparations Chronic pain | duloxetine | pregabalin | Exception Non-Steroidal Anti-Inflammatory Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0150055
UMLS CUI [2]
C0245561
UMLS CUI [3]
C0657912
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0003211
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Ähnliche Modelle

Eligibility Osteoarthritis of the Knee NCT00979953

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
a man or woman between 18 and 75 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Insertion of a contraceptive implant | Injectable contraception | Transdermal contraception | Oral Contraceptives Combination | Childbearing Potential Pregnancy test negative | Female Sterilization | Hysterectomy | Tubal Ligation | Postmenopausal state | Follicle stimulating hormone measurement | Estradiol measurement
Item
for women of childbearing potential, be using an insertable, injectable, transdermal, or combination oral contraceptive deemed highly effective by the united states food and drug administration from the first dose of study medication through the end of the study and have negative findings on pregnancy tests performed at screening and randomization (women who are surgically sterile [for example, hysterectomy, tubal ligation] or postmenopausal [if ≥55 years old, no menses for at least 2 years; if <55 years old, follicle-stimulating hormone concentrations within the postmenopausal range of >40 milli-international units per milliliter (miu/ml) and 17 β-estradiol levels of <37 picograms per milliliter (pg/ml)] are also eligible to participate)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1657105 (UMLS CUI [2])
C1262153 (UMLS CUI [3])
C1168146 (UMLS CUI [4])
C0009905 (UMLS CUI [5,1])
C0205195 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0427780 (UMLS CUI [6,2])
C0015787 (UMLS CUI [7])
C0020699 (UMLS CUI [8])
C0520483 (UMLS CUI [9])
C0232970 (UMLS CUI [10])
C0202022 (UMLS CUI [11])
C0337434 (UMLS CUI [12])
Gender Male sterilization | Gender Contraceptive methods | Contraception, Barrier | Spermatocidal Agents | Partner Female Sterilization | Partner Postmenopausal state | Partner Insertion of a contraceptive implant | Partner Injectable contraception | Partner Transdermal contraception | Partner Oral Contraceptives Combination
Item
for male participants, be surgically sterile or agree to use an appropriate method of contraception (that is, use a barrier method in conjunction with spermicide or have a sexual partner who is surgically sterile, postmenopausal, or using an insertable, injectable, transdermal, or combination oral contraceptive deemed highly effective by the united states food and drug administration) from the first dose of study medication through the end of the study
boolean
C0079399 (UMLS CUI [1,1])
C0024559 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0004764 (UMLS CUI [3])
C0037862 (UMLS CUI [4])
C0682323 (UMLS CUI [5,1])
C0015787 (UMLS CUI [5,2])
C0682323 (UMLS CUI [6,1])
C0232970 (UMLS CUI [6,2])
C0682323 (UMLS CUI [7,1])
C1657105 (UMLS CUI [7,2])
C0682323 (UMLS CUI [8,1])
C1262153 (UMLS CUI [8,2])
C0682323 (UMLS CUI [9,1])
C1168146 (UMLS CUI [9,2])
C0682323 (UMLS CUI [10,1])
C0009905 (UMLS CUI [10,2])
C0205195 (UMLS CUI [10,3])
Body Weight
Item
have a body weight between 45 and 150 kilograms (kg), inclusive
boolean
C0005910 (UMLS CUI [1])
Pain Index Knee Duration
Item
have had pain in the index knee for at least the past 6 months
boolean
C0030193 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Criteria Fulfill Knee Osteoarthritis | Diagnostic radiologic examination | Pain Index Knee | Osteophyte Moderate Quantity Radiograph | Osteophyte Definite Quantity Radiograph | Age | Morning stiffness Duration | Crepitus During Active motion
Item
meet the following criteria for osteoarthritis of the knee established by the american college of rheumatology (radiographs must have been taken within the last year; if none is available, a radiograph must be taken and the diagnostic criteria must be confirmed before the participant is enrolled in the study): have index knee pain plus at least 1 moderate or definite osteophyte on radiographs. must also have at least 1 of the following: be more than 50 years old, have morning stiffness for less than 30 minutes, or have crepitus on active motion
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])
C0043299 (UMLS CUI [2])
C0030193 (UMLS CUI [3,1])
C2986546 (UMLS CUI [3,2])
C0022742 (UMLS CUI [3,3])
C1956089 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C1306645 (UMLS CUI [4,4])
C1956089 (UMLS CUI [5,1])
C0439544 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C1306645 (UMLS CUI [5,4])
C0001779 (UMLS CUI [6])
C0457086 (UMLS CUI [7,1])
C0449238 (UMLS CUI [7,2])
C0231592 (UMLS CUI [8,1])
C0347984 (UMLS CUI [8,2])
C0231481 (UMLS CUI [8,3])
Pain Index Knee Numeric Pain Scale
Item
have an average weekly pain score of at least 4.00 on the numeric pain rating scale (nprs) for the index knee during the baseline week before randomization (to be eligible for randomization, participants must report their nprs score via the interactive voice-response system (ivrs) for at least 4 of the 7 days immediately before randomization, with the first score being recorded on day -6)
boolean
C0030193 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C1518471 (UMLS CUI [1,4])
Cyclooxygenase Inhibitors Dose Stable | Angiotensin-Converting Enzyme Inhibitors Dose Stable
Item
if receiving nonselective or selective cyclooxygenase (cox) inhibitors, have a stable daily dose regimen for at least 4 weeks before screening; if receiving nonselective or selective cox inhibitors on an as needed basis, have discontinued use by day -14; if receiving angiotensin-converting enzyme (ace) inhibitors, have a stable dose regimen for at least 4 weeks before screening
boolean
C0085387 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Arthroscopy Index Knee
Item
have undergone arthroscopy on the index knee within 6 months before study entry
boolean
C0003904 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
Severe pain Other | Interference Pain Due to Osteoarthritis
Item
have other severe pain that, in the opinion of the investigator, may impair the assessment of the pain due to osteoarthritis
boolean
C0278140 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0030193 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0029408 (UMLS CUI [2,4])
Hypersensitivity Opioids | Intolerance to Opioids | Allergy to tramadol | Intolerance to Tramadol | Hypersensitivity Tapentadol | Intolerance to Tapentadol
Item
have a history of hypersensitivity or intolerance to opioids (including tramadol and tapentadol)
boolean
C0020517 (UMLS CUI [1,1])
C0242402 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0242402 (UMLS CUI [2,2])
C3472517 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0040610 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C2001271 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C2001271 (UMLS CUI [6,2])
Kidney Disease | Liver disease | Hematological Disease | Cardiovascular Disease | Metabolic Disease | Gastrointestinal Disease | Nervous system disorder | Mental disorder | Condition Study Subject Participation Status Excluded | Condition Affecting Research results
Item
have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, hematologic, cardiovascular, metabolic, gastrointestinal, neurologic, psychiatric, or another condition that would preclude participation in the study or affect the outcome of the study
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C0348080 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C0332196 (UMLS CUI [9,3])
C0348080 (UMLS CUI [10,1])
C0392760 (UMLS CUI [10,2])
C0683954 (UMLS CUI [10,3])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Inhalation allowed | Topical corticosteroids allowed
Item
have taken oral or intramuscular corticosteroids within 30 days before study entry (inhaled or topical corticosteroids are permitted)
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0304604 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Intraarticular injection of corticosteroids Index Joint
Item
have received intra-articular injections of corticosteroids into the index joint within 12 weeks before screening
boolean
C2064783 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
Intra-Articular Injections Hyaluronic Acid Index Joint
Item
have received intra-articular injections of hyaluronic acid into the index joint within 24 weeks before screening
boolean
C0021488 (UMLS CUI [1,1])
C0020196 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0022417 (UMLS CUI [1,4])
Pharmaceutical Preparations Chronic pain | duloxetine | pregabalin | Exception Non-Steroidal Anti-Inflammatory Agents
Item
currently taking medications other than nonsteroidal anti-inflammatory drugs prescribed for chronic pain (such as duloxetine or pregabalin)
boolean
C0013227 (UMLS CUI [1,1])
C0150055 (UMLS CUI [1,2])
C0245561 (UMLS CUI [2])
C0657912 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0003211 (UMLS CUI [4,2])
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