Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)
Information source: Nycomed
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Nasal fentanyl (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Nycomed Official(s) and/or principal investigator(s):
Nycomed Clinical Trial Operations, Study Chair, Affiliation: Headquaters
Overall contact:
Nycomed Clinical Trial Operations, Phone: +45 4677 1111, Email: clinicaltrials@nycomed.com
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
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Primary endpoint:
Time to onset of meaningful pain relief recorded by stopwatch
Secondary outcome: • 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Nycomed Clinical Trial Operations, Phone: +45 4677 1111, Email: clinicaltrials@nycomed.com
Nycomed, Roskilde 4000, Denmark; Recruiting
Clinical Trial Operations, Phone: +45 4677 1111, Email: clinicaltrials@nycomed.com
Additional Information
Starting date: January 2007
Ending date: October 2008
Last updated: December 20, 2007
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