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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01045603 |
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Date of registration:
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08/01/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Instanyl® Non-Interventional Study
INIS |
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Scientific title:
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A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl® |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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309 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01045603 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Denmark
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France
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Greece
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Ireland
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Norway
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Sweden
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United Kingdom
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Contacts
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Name:
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Nycomed Clinical Trial Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Headquarters |
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Key inclusion & exclusion criteria
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- Adult cancer patients suffering from BTP
- Instanyl should be prescribed in accordance with the Summary of Product
Characteristics (SPC) and none of the stated contradictions applies
- The decision to prescribe should be made independently of the study
- All patients must provide signed Informed Consent prior to inclusion
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Breakthrough Cancer Pain
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Primary Outcome(s)
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Success of titration (Y/N), defined as reaching a maintenance dose
[Time Frame: At week 4 and month 3 after baseline]
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Dose level of Instanyl® after titration, defined as the maintenance dose
[Time Frame: At week 4 and month 3 after baseline]
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Secondary Outcome(s)
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Change in Instanyl® maintenance dose
[Time Frame: At week 4 and month 3 after baseline]
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Pain, pain relief and impact of pain of daily life
[Time Frame: At baseline and week 4]
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Reason and time for Instanyl® termination
[Time Frame: At week 4 and month 3 after baseline]
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Change in level of background medication (standardised daily dose)
[Time Frame: At week 4 and month 3 after baseline]
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Treatment satisfaction
[Time Frame: At baseline and week 4]
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Adverse Drug Reactions (ADR)
[Time Frame: At week 4 and month 3 after baseline]
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Secondary ID(s)
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U1111-1136-4251
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FT-1301-034-SP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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