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

Cancers, Pain Clinical Trial

Official title:

A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Fentanyl Citrate Nasal Spray Compared to Immediate Release Morphine Sulphate in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589823
• Other study ID #: CPO44/06/FCNS
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2007
• Last updated: January 20, 2010
• Start date: June 2007
• Est. completion date: March 2009

Study information

• Verified date: January 2010
• Source: Archimedes Development Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Description:

Current treatments for breakthrough cancer pain (BTCP)work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition many cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish.

This study will compare the time of onset and degree of pain relief of Nasalfent to that of Immediate Release Morphine Sulphate. The safety of the two treatment options will also be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Intolerance to opioids or fentanyl

• rapidly increasing/uncontrolled pain

• pain that is not cancer-related

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancers, Pain

Intervention

Drug:
• Fentanyl citrate
nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day
• Immediate release morphine sulphate
drug dose as required by patient taken to treat up to four epsiodes of BTCP per day

Locations

Country	Name	City	State
United Kingdom	Prof Fallon	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Archimedes Development Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief		Various time points	No
Secondary	Pain Relief at various time points		Various time points	No