Informed Consent
Item
subject voluntarily agrees to participate in this study and signs an irb-approved informed consent.
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status | Osteoarthritis Clinical Trial
Item
subject has participated (and not withdrawn secondary to any adverse event) in the phase 3 osteoarthritis study wl-1001-05-01 and completed end-of-study/final visit preferably < 30 days prior to day 1 of this study (wl-1001-05-04).
boolean
C2348568 (UMLS CUI [1])
C0029408 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Age
Item
subject is between 40 and 76 years of age.
boolean
C0001779 (UMLS CUI [1])
General health good
Item
subject is generally in good health.
boolean
C1277245 (UMLS CUI [1])
Protocol Compliance
Item
subject is expected to be compliant with study procedures.
boolean
C0525058 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative
Item
female subjects of child-bearing potential must have a negative urine pregnancy test at day 1.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Childbearing Potential Contraceptive method Singular Unchanged
Item
female subjects of child-bearing potential agree to use an approved form of contraception and must be on the same contraceptive method and dosage schedule during the entire study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C2346711 (UMLS CUI [1,4])
Tendonitis | Bursitis | Arthroplasty, Replacement, Partial Knee | Knee Replacement Arthroplasty
Item
presence of tendonitis, bursitis, partial or complete joint replacement of knee(s).
boolean
C0039503 (UMLS CUI [1])
C0006444 (UMLS CUI [2])
C0864243 (UMLS CUI [3])
C0086511 (UMLS CUI [4])
Dermatologic disorder Near Treatment Area Knee | Erythema | Communicable Diseases | Injury wounds | Irritation
Item
presence of active skin disease, erythema, infection, wound, or irritation near the treatment area of the knee(s).
boolean
C0037274 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205146 (UMLS CUI [1,4])
C0022742 (UMLS CUI [1,5])
C0041834 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C0043250 (UMLS CUI [4])
C1706307 (UMLS CUI [5])
Operative procedure on knee Patient need for | Invasive procedure Knee Patient need for | Synovial Fluid Aspiration | Arthroscopy | Irrigation of joint | Injectables
Item
subject has an anticipated need for any surgical or other invasive procedure (e.g., synovial fluid aspiration, arthroscopy, tidal joint irrigation, injectable medications) that will be performed on the knees during the course of the study.
boolean
C0187769 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C4048276 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0039097 (UMLS CUI [3,1])
C0349707 (UMLS CUI [3,2])
C0003904 (UMLS CUI [4])
C0408211 (UMLS CUI [5])
C0086466 (UMLS CUI [6])
Rheumatoid Arthritis | Fibromyalgia | Connective Tissue Disease | Arthritis, Psoriatic | Erosive osteoarthrosis inflammatory | skeletal hyperostosis idiopathic Diffuse | nervous system disorder Severe | Vascular Disease Severe
Item
subject has a history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory oa, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease.
boolean
C0003873 (UMLS CUI [1])
C0016053 (UMLS CUI [2])
C0009782 (UMLS CUI [3])
C0003872 (UMLS CUI [4])
C0451840 (UMLS CUI [5,1])
C0333348 (UMLS CUI [5,2])
C1399999 (UMLS CUI [6,1])
C0332240 (UMLS CUI [6,2])
C0205219 (UMLS CUI [6,3])
C0027765 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0042373 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
Gout | Pseudogout | Redness | Swelling | Fever
Item
subject has active (redness, swelling, fever, etc.) gout or pseudo-gout within 6 months prior to screening.
boolean
C0018099 (UMLS CUI [1])
C0033802 (UMLS CUI [2])
C0332575 (UMLS CUI [3])
C0038999 (UMLS CUI [4])
C0015967 (UMLS CUI [5])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Peripheral Neuropathy
Item
subject has type i or type ii diabetes with peripheral neuropathies.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0031117 (UMLS CUI [3])
Knee Injuries | Operative procedure on knee
Item
subject has had trauma or surgery to the knee(s) within 1 year prior to the enrollment period.
boolean
C0022744 (UMLS CUI [1])
C0187769 (UMLS CUI [2])
Condition Clinical Unstable | Malignant Neoplasms
Item
subject has an underlying clinical condition, including previous malignancies that in the investigator's judgment, is unstable.
boolean
C0348080 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
Hypersensitivity Capsicum extract | Hypersensitivity zucapsaicin | Hypersensitivity Product Capsaicin Containing | Hypersensitivity Capsaicin cream preparation Constituents
Item
subject has known allergy or hypersensitivity to capsicum, civamide, or capsaicin-containing products or any constituent of the cream formulation.
boolean
C0020517 (UMLS CUI [1,1])
C1095803 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0763832 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1514468 (UMLS CUI [3,2])
C0006931 (UMLS CUI [3,3])
C0332256 (UMLS CUI [3,4])
C0020517 (UMLS CUI [4,1])
C0006931 (UMLS CUI [4,2])
C0304245 (UMLS CUI [4,3])
C0729650 (UMLS CUI [4,4])
Substance Use Disorders
Item
subject has a history of substance abuse within the past 12 months.
boolean
C0038586 (UMLS CUI [1])
Pharmaceutical Preparations Use During Restriction Period
Item
use of certain medications within the given restriction period prior to randomization and during the study.
boolean
C0013227 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0443288 (UMLS CUI [1,4])
C1948053 (UMLS CUI [1,5])