Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
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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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancers, Pain |
Drug: Fentanyl citrate Drug: Immediate release morphine sulphate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- Pain Relief [ Time Frame: Various time points ] [ Designated as safety issue: No ]
- Pain Relief at various time points [ Time Frame: Various time points ] [ Designated as safety issue: No ]
| Enrollment: | 135 |
| Study Start Date: | June 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
|
|
Experimental: 2
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
|
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.
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: | Mark Watling, Group Medical Director, Archimedes Development Ltd |
| ClinicalTrials.gov Identifier: | NCT00589823 History of Changes |
| Other Study ID Numbers: | CPO44/06/FCNS |
| Study First Received: | December 27, 2007 |
| Last Updated: | January 20, 2010 |
| Health Authority: | Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control 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 United Kingdom: Research Ethics Committee India: Drugs Controller General of India |
Keywords provided by Archimedes Development Ltd:
|
Pain Cancer Breakthrough |
Additional relevant MeSH terms:
|
Fentanyl Morphine Analgesics, Opioid Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on October 17, 2012
