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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01248611
First received: November 18, 2010
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    scores on a 0-10 numerical rating scale; 0=none / 10=intolerable

  • nausea and vomiting [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248611

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

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01248611     History of Changes
Other Study ID Numbers: NFCP1-2010
Study First Received: November 18, 2010
Last Updated: May 9, 2014
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by St. Olavs Hospital:
pain
adverse effects
safety
feasibility

Additional relevant MeSH terms:
Fentanyl
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
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 29, 2014