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

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Nasal fentanyl
Sponsored by
Nycomed
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring breakthrough pain in patients with cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nycomed

Outcomes

Primary Outcome Measures

Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch

Secondary Outcome Measures

• 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

Full Information

First Posted
July 3, 2007
Last Updated
May 4, 2012
Sponsor
Nycomed
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1. Study Identification

Unique Protocol Identification Number
NCT00496392
Brief Title
Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nycomed

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
breakthrough pain in patients with cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nasal fentanyl
Other Intervention Name(s)
Instanyl
Intervention Description
Breakthrough pain in patients with breast or prostate cancer
Primary Outcome Measure Information:
Title
Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
• 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
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nycomed Clinical Trial Operations
Organizational Affiliation
Headquaters
Official's Role
Study Chair
Facility Information:
Facility Name
Nycomed
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19792837
Citation
Mercadante S, Radbruch L, Davies A, Poulain P, Sitte T, Perkins P, Colberg T, Camba MA. A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin. 2009 Nov;25(11):2805-15. doi: 10.1185/03007990903336135.
Results Reference
derived

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

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