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Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer (NFCP1-2010)

This study has been completed.
Information provided by (Responsible Party):
St. Olavs Hospital Identifier:
First received: November 18, 2010
Last updated: May 9, 2014
Last verified: May 2014
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 medication. So far opioids for self-administration with a rapid onset of action have not been available. Recently a nasal formulation of fentanyl (an opioid similar to morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable pain with short duration that breaks through the otherwise stable pain controlled with the around the clock medication. The basic idea is that this formulation may open for patient controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of nasally delivered fentanyl. This means that the patient only takes medication when in pain. This single center feasibility / safety study is the first part of a study to investigate this alternative cancer pain treatment approach.

Condition Intervention Phase
Chronic Pain Cancer Drug: fentanyl Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer An Open Label Prospective Phase I b Study

Resource links provided by NLM:

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • sedation/drowsiness [ Time Frame: 10 days ]
    scores on a 0-10 numerical rating scale; 0=none / 10=intolerable

  • nausea and vomiting [ Time Frame: 10 days ]
    nausea scores on a 0-10 numerical rating scale; 0=none / 10=intolerable vomiting yes/no

Secondary Outcome Measures:
  • pain intensity [ Time Frame: 10 days ]
    scores on a 0-10 numerical rating scale; 0=none / 10=intolerable

Enrollment: 10
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fentanyl
cancer patients with pain
Drug: fentanyl
nasally, dose titrated to effect
Other Name: Instanyl (nNcomed Pharma)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Cancer patients with metastatic disease
  2. Adult (older than 18 years)
  3. Life expectancy of > 3 months
  4. Cancer-related pain > 3 on an 11 point Numerical Rating Scale (NRS)
  5. In the need of opioids (step II or III)
  6. Able to use nasal drugs.
  7. Women of child bearing potential using adequate contraception
  8. 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 Criteria:

  1. History of substance abuse
  2. Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures
  3. Treated with MAO inhibitor within the last 14 days
  4. Known hypersensitivity to study drug or specific contraindications to the study drug
  5. Nasopharyngeal device such as gastric tube
  6. 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
  7. Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
  8. Sleep apnoea syndrome
  9. Pregnant or breastfeeding women
  10. Psychiatric disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT01248611

St.Olavs University Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Principal Investigator: Stein Kaasa, MD. PhD St.Olav's Hospital
  More Information

Responsible Party: St. Olavs Hospital Identifier: NCT01248611     History of Changes
Other Study ID Numbers: NFCP1-2010
Study First Received: November 18, 2010
Last Updated: May 9, 2014

Keywords provided by St. Olavs Hospital:
adverse effects

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on August 17, 2017