MedTrace Logo

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

NCT00496392 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2012-05-07

No results posted yet for this study

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

Conditions

Interventions

DRUG

Nasal fentanyl

Breakthrough pain in patients with breast or prostate cancer

Sponsors & Collaborators

  • Nycomed

    lead INDUSTRY

Principal Investigators

  • Nycomed Clinical Trial Operations · Headquaters

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-08-31
Completion
2009-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00496392 on ClinicalTrials.gov