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Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain
This study has been completed.
Sponsor:
Archimedes Development Ltd
Information provided by (Responsible Party):
Archimedes Development Ltd
ClinicalTrials.gov Identifier:
NCT00458510
First received: April 10, 2007
Last updated: July 10, 2013
Last verified: July 2013
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | April 10, 2007 | |||
| Last Updated Date | July 10, 2013 | |||
| Start Date ICMJE | January 2007 | |||
| Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Long term Safety, tolerability and acceptability [ Time Frame: End of study ] | |||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00458510 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain | |||
| Official Title ICMJE | An Open-Label Study Investigating Long-Term Safety and Tolerability of Fentanyl Citrate Nasal Spray in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy | |||
| 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 examine the long-term 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 examine the long-term safety of Nasalfent treatment for breakthrough cancer pain. After the study is completed, patients may continue to take medication if their doctor feels it is in the patient's best interest to do so. Safety information will continue to be collected during this period. Treatment may continue on study for as long as the patient requires treatment or until Nasalfent becomes commercially available. |
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| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE | Cancers, Pain | |||
| Intervention ICMJE | Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
treatment of up to 4 episodes of pain per day
Other Name: FCNS |
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| Study Arms | Experimental: Fentanyl, Open-Label treatment
All patients take NasalFent at effective dose to treat up to four episodes of breakthrough cancer pain per day
Intervention: Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) |
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| Publications * | Taylor D, Radbruch L, Revnic J, Torres LM, Ellershaw JE, Perelman MS. Long-term use of fentanyl pectin nasal spray in patients with breakthrough pain in cancer [abstract]. J Clin Oncol. 2013:31(15 Suppl);9563 | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 403 | |||
| Completion Date | July 2012 | |||
| Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | United States | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00458510 | |||
| Other Study ID Numbers ICMJE | CPO45/06/FCNS | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Archimedes Development Ltd | |||
| Study Sponsor ICMJE | Archimedes Development Ltd | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Archimedes Development Ltd | |||
| Verification Date | July 2013 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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