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Completed

NCT Number: NCT01248611

Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer

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.

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Key information

Conditions

Chronic Pain Cancer Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St.Olavs University Hospital

Trondheim, 7006, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Fentanyl

Drug

nasally, dose titrated to effect

Other names: Instanyl (nNcomed Pharma)

Primary outcomes

  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 outcomes

  1. pain intensity

    Time frame: 10 days

    scores on a 0-10 numerical rating scale; 0=none / 10=intolerable

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study title

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

Acronym: NFCP1-2010

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2010
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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