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Clinical Trials/NCT00496392
NCT00496392CompletedPhase 3

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

Nycomed2 sites in 1 country115 target enrollmentStarted: January 1, 2007Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Nycomed
Enrollment
115
Locations
2
Primary Endpoint
Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: 26 weeks

Secondary Outcomes

  • • 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)

Investigators

Sponsor
Nycomed
Sponsor Class
Industry

Study Sites (2)

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