Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancers, Pain |
Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | 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 |
- Long term Safety, tolerability and acceptability [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
| Enrollment: | 403 |
| Study Start Date: | January 2007 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fentanyl, Open-Label treatment
All patients take NasalFent at effective dose to treat up to four episodes of breakthrough cancer pain per day
|
Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
treatment of up to 4 episodes of pain per day
Other Name: FCNS
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Archimedes Development Ltd |
| ClinicalTrials.gov Identifier: | NCT00458510 History of Changes |
| Other Study ID Numbers: | CPO45/06/FCNS |
| Study First Received: | April 10, 2007 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Czech Republic: State Institute for Drug Control Costa Rica: Ministry of Health Costa Rica France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Archimedes Development Ltd:
|
Pain Cancer Breakthrough |
Additional relevant MeSH terms:
|
Citric Acid Fentanyl Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Central Nervous System Agents |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 23, 2013