Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
NCT ID: NCT02899884
Last Updated: 2019-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
3765 participants
OBSERVATIONAL
2016-11-14
2018-07-16
Brief Summary
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Detailed Description
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The study enrolled 3765 patients. This multicenter trial will be conducted in Spain. Data from participants will be collected through questionnaire and medical history in a single visit (up to 1 month).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
No Intervention
Interventions
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No Intervention
Eligibility Criteria
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Inclusion Criteria
* Participants with baseline cancer pain that is adequately controlled with opioids
* Presence of episodes of breakthrough pain associated with the cancer pain
* Meeting the diagnostic criteria for breakthrough cancer pain (participant history and Portenoy's criteria) and the Davies algorithm
* Participants who are not receiving treatment for breakthrough cancer pain. It is not permitted the inclusion of participants receiving treatment for breakthrough cancer pain in order to avoid bias that may affect the characterization or taxonomy of breakthrough cancer pain
* Signing of the informed consent
Exclusion Criteria
* Any medical condition or situation complicating the collection of study data as determined by the investigator
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Hospital General Universitario de Elda-Virgen de La Salud
Elda, Alicante, Spain
Hospital Universitario San Juan de Alicante
San Juan, Alicante, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Especialidades de Puerto Real
Puerto Real, Cadiz, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Canary Islands, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canarias, Canary Islands, Spain
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital de Alta Resolucion de Guadix
Guadix, Granada, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario Puerta de Hierro, Majadahonda
Majadahonda, Madrid, Spain
Hospital Quiron Madrid
Pozuelo de Alarcón, Madrid, Spain
Complejo Hospital Costa Del Sol
Marbella, Malaga, Spain
Hospital General Universitario Santa Lucia
Cartagena, Murcia, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Los Montalvos
Carrascal de Barregas, Salamanca, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, , Spain
Centro Oncoloxico de Galicia
A Coruña, , Spain
Hospital Torrecardenas
Almería, , Spain
Hospital Puerta Del Mar
Cadiz, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Complejo Hospitalario de Jaen
Jaén, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Complejo Hospitalario Regional de Malaga
Málaga, , Spain
Hospital Virgen de La Victoria
Málaga, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Nuestra Senora de Valme
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CARPEDIO Study
Identifier Type: OTHER
Identifier Source: secondary_id
Fentanyl-5001
Identifier Type: -
Identifier Source: org_study_id
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