Instanyl® Non-Interventional Study

Completed

• Conditions: Breakthrough Cancer Pain

• Registration Number: NCT01045603
• Lead Sponsor: Takeda

Brief Summary

The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-26
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success of titration (Y/N), defined as reaching a maintenance dose	At week 4 and month 3 after baseline
Dose level of Instanyl® after titration, defined as the maintenance dose	At week 4 and month 3 after baseline

Secondary Outcome Measures

Name	Time	Method
Adverse Drug Reactions (ADR)	At week 4 and month 3 after baseline
Reason and time for Instanyl® termination	At week 4 and month 3 after baseline
Change in Instanyl® maintenance dose	At week 4 and month 3 after baseline
Change in level of background medication (standardised daily dose)	At week 4 and month 3 after baseline
Pain, pain relief and impact of pain of daily life	At baseline and week 4
Treatment satisfaction	At baseline and week 4

Trial Locations

Locations (1)

Investigational site; 🇬🇧 Wiltshire, United Kingdom