Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

Pain Clinical Trial

Official title:

An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496392
• Other study ID #: FT-019-IM
• Secondary ID: 2006-002087-26
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2007
• Last updated: May 4, 2012
• Start date: January 2007
• Est. completion date: October 2009

Study information

• Verified date: May 2012
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthGermany: Paul-Ehrlich-InstitutItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

Primary:

• To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients.

Secondary:

• To compare patients' general impression and preference of NF and Actiq

• To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid

• To assess safety and tolerability of NF

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: October 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain.

• Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months.

• Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed.

• Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed.

• Previous use of Actiq is accepted.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breakthrough Pain
• Pain

Intervention

Drug:
• Nasal fentanyl
Breakthrough pain in patients with breast or prostate cancer

Locations

Country	Name	City	State
Denmark	Nycomed	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch		26 weeks	Yes
Secondary	• Pain Intensity Differences (PID) at 10 and 30 min derived from Pain Intensity (PI) scores • Sum of Pain Intensity Differences (SPID) 0-15 and 0-60 derived from PI scores • Time to 50% reduction in PI scores • General impression (GI) of the t		26 weeks	Yes