Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459277
Status:
COMPLETED
Last Update Posted:
2012-01-25
First Post:
2007-04-10
Brief Title:
Efficacy Safety Study of Nasalfent Fentanyl Citrate Nasal Spray for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
Sponsor:
Archimedes Development Ltd
Organization:
Archimedes Development Ltd
Study Overview
Official Title:
A Multicenter Placebo-Controlled Double-Blind Two-Phase Crossover Study of Nasalfent Fentanyl Citrate Nasal Spray in the Treatment of Breakthrough Cancer Pain BTCP in Subjects Taking Regular Opioid Therapy
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 pain killer 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 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 most 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 Placebo The safety of the two treatments groups Nasalfent Placebo will also be examined
This study will compare the time of onset and degree of pain relief of Nasalfent to that of Placebo The safety of the two treatments groups Nasalfent Placebo will also be examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None