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A Study of Fentanyl Nasal Spray Safety and Effectiveness for Pain Management in Patients Requiring Pain Relief

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at pain management in patients with cancer who experience severe sudden pain, also called breakthrough pain, despite being on regular strong pain medication. The study will use fentanyl given as a nasal spray, which is a powerful pain relief medicine. Two forms of fentanyl will be used in the study: Fentanyl Kalceks and Fentanyl Sandoz, both given through the nose as a spray instead of by injection as they are normally used.

The purpose of the study is to collect information through questionnaires about how well fentanyl nasal spray works and how safe it is for treating breakthrough pain in cancer patients. The study is designed for adults over 18 years old who have cancer and are already taking major opioid therapy, which means they are already using strong pain medicines regularly. Patients need to be able to think clearly, use the nasal spray by themselves, and have a breathing rate above 10 breaths per minute. The study will not include patients who are pregnant or breastfeeding, have cancerous tumors in the mouth or nose, or have a known allergy to fentanyl.

During the study, patients will use the fentanyl nasal spray when they have episodes of severe sudden pain and will answer questions about how well it relieves their pain. The study will measure success by looking at the responder rate using a pain rating scale called NPRS, which helps track how much the pain improves after using the spray. The treatment period for each patient can last up to 6 months, and the entire study is expected to continue until March 2026.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and enrollment

    Your medical condition will be assessed to confirm that you have severe cancer with acute pain episodes (also called breakthrough pain) that occur despite your regular pain relief treatment.

    Your current pain treatment will be reviewed to confirm that you are receiving major opioid therapy, which means strong pain medication on a regular basis.

    Your mental state will be evaluated to ensure you have a clear state of mind and can understand the study procedures.

    Your ability to use a nasal spray by yourself will be checked.

    You will be asked about pregnancy or breastfeeding status to confirm you are not pregnant or breastfeeding.

    A check will be performed to ensure you do not have cancerous tumors in your mouth or nose area.

    Your breathing rate will be measured to confirm it is above 10 breaths per minute.

    You will be asked about any known allergy to fentanyl, which is the active ingredient in the nasal spray.

  2. Step 2

    Treatment with fentanyl nasal spray

    You will receive Fentanyl nasal spray to use when you experience episodes of severe, acute pain that break through your regular pain medication.

    The nasal spray contains fentanyl at a concentration of 50 micrograms per milliliter.

    You will administer the spray yourself into your nose when needed for breakthrough pain episodes.

    The specific dosage, frequency of use, and total duration of treatment will be determined based on your individual pain management needs during routine care.

  3. Step 3

    Pain assessment and monitoring

    Your pain levels will be assessed using the NPRS scale (Numeric Pain Rating Scale), which is a simple scale where you rate your pain intensity using numbers.

    You will be asked to complete questionnaires about how well the fentanyl nasal spray works for your pain relief.

    Information will be collected about any side effects or safety concerns you experience while using the nasal spray.

    These assessments will continue throughout your participation in the study.

  4. Step 4

    Completion of study participation

    Your participation in the study is expected to continue until the study ends, which is estimated to be in March 2026.

    Final questionnaires about the effectiveness and safety of the fentanyl nasal spray will be completed.

    All collected information about your pain relief response and any side effects will be recorded for the study analysis.

Who can join the trial?

11 criteria

  • You must be over 18 years old
  • You must have cancer and be receiving treatment for pain
  • You must have severe, sudden pain that occurs even though you are already taking regular pain medication. This is called breakthrough pain, which means pain that breaks through your usual pain treatment
  • You must be taking major opioid therapy, which means strong pain medicines that contain substances like morphine or similar drugs
  • You must have a clear state of mind, meaning you are able to think clearly and understand instructions
  • You must be able to use the nasal spray by yourself, which is a medicine device that sprays medication into your nose
  • You must not be pregnant
  • You must not be breastfeeding
  • You must not have cancerous tumors in your mouth or nose
  • Your breathing rate must be above 10 breaths per minute
  • You must not have a known allergy to fentanyl, which is the active medicine in the nasal spray

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria have been provided for this clinical trial
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Investigated drugs

Fentanyl Nasal Spray is a pain medication that is sprayed into the nose. It works quickly to relieve severe pain by acting on the brain and nervous system. This nasal spray is being tested in this study to see how well it works and how safe it is for patients.

What is already known about the treatment

Fentanyl Nasal Spray – Fentanyl nasal spray is a medication administered through the nose by spraying it into the nostrils, designed for pain management in patients who require strong pain relief. This medicine is an authorized treatment that belongs to the group of opioid pain relievers and works by attaching to specific receptors in the brain and nervous system that control pain signals, effectively blocking the sensation of pain. At the molecular level, fentanyl binds to opioid receptors called mu-receptors, which changes how the body perceives and responds to pain. This nasal spray formulation allows for rapid absorption through the nasal membranes, making it particularly useful for breakthrough pain episodes that need quick relief.

Investigated diseases

Pain – Pain is an unpleasant sensory and emotional experience that occurs when the body detects actual or potential tissue damage. It serves as a protective mechanism to alert the body to harm or injury. Pain can be acute, lasting for a short period, or chronic, persisting for months or longer. The intensity of pain can range from mild discomfort to severe and debilitating sensations. Pain signals travel from the affected area through nerves to the brain, where they are processed and perceived. Various factors including inflammation, nerve damage, or disease can trigger or maintain pain sensations in the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519131-42-02Estimated enrolment50 patientsSponsorSemmelweis University

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