Breakthrough pain MedDRA version: 8.1 Level: PT Classification code 10064556
Conditions
Interventions
Product Name: Nasal Fentanyl
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Fentanyl Citrate
CAS Number: 990-73-8
Concentration unit: µg microgram(s)
Concentration type: equal
Concent
Sponsors
Nycomed Danmark ApS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All inclusion criteria must be answered "yes" Has the patient given informed consent according to applicable requirements before any trial-related activities Is the patient a cancer patient with breakthrough pain (BTP) Is the patient 18 years or above Has the patient received for at least the past month either oral morphine, oxycodone, hydromorphone or transdermal fentanyl for treatment of background pain Is the current dose of the scheduled background pain opioid of the patient equivalent to 60-500 mg oral morphine/day or to transdermal fentanyl 25-200µg/hour Is the background pain gererally stable and on average controlled to a mild level by the background pain opioid Is the BTP episodes in general of so severe pain intensity that the patient judges he/she needs additional analgesics( apart from background pain medication) In general does the patient have at least three BTP episodes per week but no more than four BTP episodes per day while using a stable fixed-schedule opioid regimen Has the patient obtained at least partial relief of BTP with his/her usual immediate release strong opioid i.e. morphine, oxycodone, hydromorphine or transmucosal fentanyl Is the life expectancy of the patient at least 3 months Is the patient able to use nasal drugs For female patients of child bearing potential: Does the patient use adequate contraceptive precaution in the trial period Does the patient have a negative urine or blood pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All exclusion criteria must be answered "no" Does the patient have a recent history of substance abuse Is the patient pregnant or nursing during the trial period Has the patient neurological or psychiatric impairment that may compromise data collection Has the patient severe hepatic impairment Has the patient had any recent therapy which could potentially alter pain response to analgesics to a degree where the need for background pain opioid will be less than 60 mg morphine or morphine equivalents/day or less than 25µg/hour transdermal fentanyl or the number of BTP episodes will be less than three per week during the trial period Has the patient ever had oral/nasal surgery or facial radiotherapy ? (Tooth extraction performed more than 30 days prior to screening is allowed) Has the patient received radiotherapy within the last 30 days or is the patient scheduled to receive radiotherapy within the next 8 weeks Has the patient been treated with MAO inhibitor within the last 14 days Has the patient been treated with Methadone within the last 32 days Has the patient been treated with Buprenorphine within the last 16 days Does the patient have an impaired respiratory function to an extent which may severely increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment Does the patient use drugs for nasal administration Does the patient have nasopharyngeal probe Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients Has the patient any head injury, primary brain tumour or other pathological conditions which could significantly increase the risk of increased intracranial pressure or impaired consciousness Has the patient concomitant participation in any other trial with an investigational drug or device apart from cancer treatment within 30 days prior to inclusion in this trial Does the patient have pathological conditions of the nasal and/or oral cavity as contraindication to nasal fentanyl or Actiq Was the patient included in FT-016-IM, FT-017-IM or FT-018-IM
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of nasal fentanyl to oral transmucosal fentanyl (Actiq) in the management of breakthrough pain in cancer patients;Secondary Objective: To compare patient's general impression and preference of nasal fentanyl and Actiq To explore the relationship between nasal fentanyl doses and doses of current opioid for brakthrough pain and the relationship between dose of nasal fentanyl and of background opioid To assess safety and tolerability of nasal fentanyl;Primary end point(s): Time to onset of meaningful pain relief recorded by stopwatch | — |
Countries
Austria, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed