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OpenTrials
Completed

NCT Number: NCT01045603

Instanyl® Non-Interventional Study

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.

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Key information

Conditions

Breakthrough Cancer Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational site, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Success of titration (Y/N), defined as reaching a maintenance dose

    Time frame: At week 4 and month 3 after baseline

  2. Dose level of Instanyl® after titration, defined as the maintenance dose

    Time frame: At week 4 and month 3 after baseline

Secondary outcomes

  1. Adverse Drug Reactions (ADR)

    Time frame: At week 4 and month 3 after baseline

  2. Reason and time for Instanyl® termination

    Time frame: At week 4 and month 3 after baseline

  3. Change in Instanyl® maintenance dose

    Time frame: At week 4 and month 3 after baseline

  4. Change in level of background medication (standardised daily dose)

    Time frame: At week 4 and month 3 after baseline

  5. Pain, pain relief and impact of pain of daily life

    Time frame: At baseline and week 4

  6. Treatment satisfaction

    Time frame: At baseline and week 4

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®

Acronym: INIS

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2010
Registry last updated
Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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