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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01248611
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : May 12, 2014
Information provided by (Responsible Party):
St. Olavs Hospital

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 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 or disease Intervention/treatment Phase
Chronic Pain Cancer Drug: fentanyl Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : January 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: fentanyl
cancer patients with pain
Drug: fentanyl
nasally, dose titrated to effect
Other Name: Instanyl (nNcomed Pharma)

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

  2. 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 :
  1. pain intensity [ Time Frame: 10 days ]
    scores on a 0-10 numerical rating scale; 0=none / 10=intolerable

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01248611

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

Publications of Results:
Responsible Party: St. Olavs Hospital Identifier: NCT01248611     History of Changes
Other Study ID Numbers: NFCP1-2010
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 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