Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)
Phase 3
Completed
- Conditions
- Pain
- Registration Number
- NCT00496392
- Lead Sponsor
- Nycomed
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch 26 weeks
- Secondary Outcome Measures
Name Time Method • 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
Trial Locations
- Locations (1)
Nycomed
🇩🇰Roskilde, Denmark