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

Sponsor:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00496392

Purpose

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

Condition	Intervention	Phase
Pain	Drug: Nasal fentanyl	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Nycomed:

Primary Outcome Measures:

Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	115
Study Start Date:	January 2007
Study Completion Date:	October 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Breakthrough pain in patients with breast or prostate cancer

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496392

Locations

Denmark
Nycomed
Roskilde, Denmark, 4000

Sponsors and Collaborators

Nycomed

Investigators

Study Chair:

Nycomed Clinical Trial Operations

Headquaters

More Information

No publications provided by Nycomed

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Mercadante S, Radbruch L, Davies A, Poulain P, Sitte T, Perkins P, Colberg T, Camba MA. A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin. 2009 Nov;25(11):2805-15.

Responsible Party:	Nycomed ( Nycomed )
Study ID Numbers:	FT-019-IM, 2006-002087-26
Study First Received:	July 3, 2007
Last Updated:	January 22, 2010
ClinicalTrials.gov Identifier:	NCT00496392 History of Changes
Health Authority:	France: Ministry of Health; Germany: Paul-Ehrlich-Institut; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; United Kingdom: National Health Service

Keywords provided by Nycomed:

breakthrough pain in patients with cancer

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010