ID

23476

Description

A Phase 3 Study to Evaluate the Long-Term Safety of ThermoProfen™ in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee.; ODM derived from: https://clinicaltrials.gov/show/NCT00532038

Lien

https://clinicaltrials.gov/show/NCT00532038

Mots-clés

  1. 06/07/2017 06/07/2017 -
Téléchargé le

6 juillet 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Osteoarthritis NCT00532038

Eligibility Osteoarthritis NCT00532038

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient completed a previous efficacy study of thermoprofen.
Description

ID.1

Type de données

boolean

Alias
UMLS CUI [1]
C0008976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a known allergy to nonsteroidal anti-inflammatory drugs (nsaids) (including aspirin).
Description

ID.2

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0746949
patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in thermoprofen (such as that found in adhesive bandages, e.g. band-aid®).
Description

ID.3

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
patient has asthma that has been induced or made worse by the use of aspirin or any other nsaid.
Description

ID.4

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0004057
UMLS CUI [1,3]
C0003211
patient has a relevant history of serious gastrointestinal disease.
Description

ID.5

Type de données

boolean

Alias
UMLS CUI [1]
C0017178
patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
Description

ID.6

Type de données

boolean

Alias
UMLS CUI [1]
C0037274
patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
Description

ID.7

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0004936
patient is taking warfarin, heparin, or low molecular weight heparin.
Description

ID.8

Type de données

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0019134
UMLS CUI [1,3]
C0019139
patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
Description

ID.9

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0009862

Similar models

Eligibility Osteoarthritis NCT00532038

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patient completed a previous efficacy study of thermoprofen.
boolean
C0008976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.2
Item
patient has a known allergy to nonsteroidal anti-inflammatory drugs (nsaids) (including aspirin).
boolean
C0020517 (UMLS CUI [1,1])
C0746949 (UMLS CUI [1,2])
ID.3
Item
patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in thermoprofen (such as that found in adhesive bandages, e.g. band-aid®).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
ID.4
Item
patient has asthma that has been induced or made worse by the use of aspirin or any other nsaid.
boolean
C0004096 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
ID.5
Item
patient has a relevant history of serious gastrointestinal disease.
boolean
C0017178 (UMLS CUI [1])
ID.6
Item
patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
boolean
C0037274 (UMLS CUI [1])
ID.7
Item
patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
boolean
C0027765 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
ID.8
Item
patient is taking warfarin, heparin, or low molecular weight heparin.
boolean
C0043031 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0019139 (UMLS CUI [1,3])
ID.9
Item
patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0009862 (UMLS CUI [1,3])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial