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

Nycomed115 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Pain

Interventions

Nasal fentanylDRUG

Breakthrough pain in patients with breast or prostate cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Nycomed

Roskilde, Denmark

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

Time frame: 26 weeks

Data from ClinicalTrials.gov

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