Status:
COMPLETED
Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer
Lead Sponsor:
St. Olavs Hospital
Conditions:
Chronic Pain
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Traditionally cancer pain is treated with long acting opioids such as morphine around the clock. However, there is no evidence that all patients have a stable pain requiring around the clock medicatio...
Eligibility Criteria
Inclusion
- Cancer patients with metastatic disease
- Adult (older than 18 years)
- Life expectancy of \> 3 months
- Cancer-related pain \> 3 on an 11 point Numerical Rating Scale (NRS)
- In the need of opioids (step II or III)
- Able to use nasal drugs.
- Women of child bearing potential using adequate contraception
- Informed consent given according to applicable requirements before any trial-related activities. Trial-related activities are any procedure that would not have been performed during the routine management of the patient
Exclusion
- History of substance abuse
- Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures
- Treated with MAO inhibitor within the last 14 days
- Known hypersensitivity to study drug or specific contraindications to the study drug
- Nasopharyngeal device such as gastric tube
- Concomitant participation in any other trials dealing with pain with an investigational drug or device apart from cancer treatment within 14 days prior to inclusion in this trial
- Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
- Sleep apnoea syndrome
- Pregnant or breastfeeding women
- Psychiatric disease
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01248611
Start Date
January 1 2011
End Date
September 1 2011
Last Update
May 12 2014
Active Locations (1)
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1
St.Olavs University Hospital
Trondheim, Norway, 7006