A comparative study of nasal fentanyl vs oral transmucosal fentanyl (Actiq) for pain in patients with cancer

Active, not recruiting

• Conditions: Breakthrough pain; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]; MedDRA version: 14.1Level: PTClassification code 10064556Term: Breakthrough painSystem Organ Class: 10018065 - General disorders and administration site conditions

• Registration Number: EUCTR2006-002087-26-ES
• Lead Sponsor: ycomed Danmark ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-15
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 115

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

Local regulatory requirements will be described in Appendix 2.
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 115
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115

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 21 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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>To explore the relationship between nasal fentanyl doses and doses of current opioid for breakthrough pain and the relationship between dose of nasal fentanyl and of background opioid<br>To assess safety and tolerability of nasal fentanyl;Primary end point(s): Time to onset of meaningful pain relief recorded by stopwatch;Timepoint(s) of evaluation of this end point: 26 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain Intensity Differences (PID) at 10 and 30 min derived from Pain Intensity (PI) scores <br>Sum of Pain Intensity Differences (SPID) 0-15 and 0-60 derived from PI scores <br>Time to 50% reduction in PI scores <br>General impression (GI) of the treatment after 60 min<br>Ease of Administration of each treatment<br>Patients preference for the two treatments (either/or)<br>Adverse events;Timepoint(s) of evaluation of this end point: 26 weeks