An open label, comparative, randomised, balanced crossover trial comparing nasal fentanyl and oral transmucosal fentanyl (Actiq) in breakthrough pain in patients with cancer - ND

Active, not recruiting

• Conditions: breakthrough pain in patients with cancer; Level: PTClassification code 10058019

• Registration Number: EUCTR2006-002087-26-IT
• Lead Sponsor: YCOMED (HEADQUARTER)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-16
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

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

Inclusion Criteria

All inclusion criteria must be answered ''yes'' 1.Has the patient given informed consent according to applicable requirements before any trial-related activities? 2.Is the patient a cancer patient with breakthrough pain (BTP)? 3.Is the patient 18 years or above? 4.Has the patient received for at least the past month either oral morphine, oxycodone, hydromorphone or transdermal fentanyl for treatment of background pain? 5.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 25-200?g/hour 6.Is the background pain gererally stable and on average controlled to a mild level (defined as <=4 on an 11 point NRS)by the background pain opioid? 7.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)? 8.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? 9.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? 10.Is the life expectancy of the patient at least 3 months? 11.Is the patient able to use nasal drugs? For female patients of child bearing potential: 12.Does the patient use adequate contraceptive precaution in the trial period? 13.Does the patient have a negative urine or blood pregnancy test? 14.was the backgroung pain during minimum five of the seven days controlled to a mild level (defined as <=4 on an 11 point NRS)by the background pain opioid? 15.did the patient have at least three BTP episodes during the seven days but no more than four BTP episodes per day? 16.was the BTP(s) of such severe pain intensity that the patient took additional analgesics (apart from the usual pain opioid)?
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

All exclusion criteria must be answered ''no'' 1.Does the patient have a recent history of substance abuse? 2.Is the patient pregnant or nursing during the trial period? 3.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 25?g/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

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 (NF) to oral transmucosal fentanyl (Actiq) (hereafter Actiq) in the management of break through pain in cancer patients.;Secondary Objective: To compare patients? general impression and preference of NF and Actiq To explore the relationship between NF doses and doses of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid To assess safety and tolerability of NF;Primary end point(s): time of onset of meaningful pain relief recorded by stopwatch.