Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

NCT00589823 | Completed Phase 3

• 1 other identifier: CPO44/06/FCNS
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting painkiller often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent compared to Immediate Release Morphine Sulphate in the treatment of breakthrough cancer pain.

Conditions

Cancers, Pain

Keywords

Pain; Cancer; Breakthrough

Outcome Measures

Primary Outcomes (1)

• Pain Relief

  Various time points

Secondary Outcomes (1)

• Pain Relief at various time points

  Various time points

Study Arms (2)

1

ACTIVE COMPARATOR

Immediate Release Morphine sulphate capsules taken at start of relevant BTCP episode. Each episode treated with either this medication OR the experimental comparator.

Drug: Fentanyl citrate

2

EXPERIMENTAL

Nasalfent spray taken at start of relevant BTCP episode. Each episode to be treated with either this medication OR the active comparator (IRMS)

Drug: Immediate release morphine sulphate

Interventions

Fentanyl citrate DRUG

nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day

Also known as: FCNS, Nasalfent

1

Immediate release morphine sulphate DRUG

drug dose as required by patient taken to treat up to four epsiodes of BTCP per day

Also known as: IRMS

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give consent
• Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception
• Diagnosis of cancer
• Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain
• Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication
• Able (or via caregiver) to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary
• Able to be up and about for 50% of the day or greater

You may not qualify if:

• Intolerance to opioids or fentanyl
• rapidly increasing/uncontrolled pain
• pain that is not cancer-related

Sponsors & Collaborators

• Archimedes Development Ltd: lead

Study Sites (1)

Prof Fallon

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marie Fallon

  Western General Hospital, Edinburgh Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 10, 2008
• Study Start: June 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 22, 2010

Record last verified: 2010-01

Locations

GB (1)