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

May 9, 2014 updated by: St. Olavs Hospital

Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer An Open Label Prospective Phase I b Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7006
        • St.Olavs university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fentanyl
cancer patients with pain
Drug: fentanyl
nasally, dose titrated to effect
Other Names:
  • Instanyl (nNcomed Pharma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sedation/drowsiness
Time Frame: 10 days
scores on a 0-10 numerical rating scale; 0=none / 10=intolerable
10 days
nausea and vomiting
Time Frame: 10 days
nausea scores on a 0-10 numerical rating scale; 0=none / 10=intolerable vomiting yes/no
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: 10 days
scores on a 0-10 numerical rating scale; 0=none / 10=intolerable
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Investigators

  • Principal Investigator: Stein Kaasa, MD. PhD, St.Olav's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFCP1-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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