Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
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|ClinicalTrials.gov Identifier: NCT00589823|
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : January 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cancers, Pain||Drug: Fentanyl citrate Drug: Immediate release morphine sulphate||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Active Comparator: 1
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
nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day
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
drug dose as required by patient taken to treat up to four epsiodes of BTCP per day
Other Name: IRMS
- Pain Relief [ Time Frame: Various time points ]
- Pain Relief at various time points [ Time Frame: Various time points ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589823
|Edinburgh, United Kingdom|
|Principal Investigator:||Marie Fallon||Western General Hospital, Edinburgh Cancer Centre|