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

Phase 3

Completed

• Conditions: Cancers, Pain
• Interventions: Drug: Fentanyl citrate; Drug: Immediate release morphine sulphate

• Registration Number: NCT00589823
• Lead Sponsor: Archimedes Development Ltd

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.

Detailed 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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2008-01-10
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-01
• Disposition First Submitted: 2010-01-20
• Disposition First Submitted QC: 2010-01-20
• Last Update Submitted: 2010-01-20
• Disposition First Posted: 2010-01-22
• Last Update Posted: 2010-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Fentanyl citrate	Immediate Release Morphine sulphate capsules taken at start of relevant BTCP episode. Each episode treated with either this medication OR the experimental comparator.
2	Immediate release morphine sulphate	Nasalfent spray taken at start of relevant BTCP episode. Each episode to be treated with either this medication OR the active comparator (IRMS)

Primary Outcome Measures

Name	Time	Method
Pain Relief	Various time points

Secondary Outcome Measures

Name	Time	Method
Pain Relief at various time points	Various time points

Trial Locations

Locations (1)

Prof Fallon; 🇬🇧 Edinburgh, United Kingdom