Status:
COMPLETED
Efficacy and Safety of Intranasal Fentanyl in the Treatment of Breakthrough Pain (FT-018-IM)
Lead Sponsor:
Nycomed
Conditions:
Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Primary objectives: * To confirm the efficacy of intranasal fentanyl titrated to doses 50, 100 or 200 µg for treatment of breakthrough pain (BTP) in cancer patients * To establish long-term safety of...
Eligibility Criteria
Inclusion
- Has the patient given informed consent according to local 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
- Is the patient a cancer patient with breakthrough pain?
- Is the patient aged ≥18 years?
- 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 opioid of the patient equivalent to 60-500 mg oral morphine/day or to transdermal fentanyl 25-200 µg/hour? For conversion table.
- Is the background pain generally stable and on average controlled to a mild level (defined as ≤4 on an 11 point NRS) by the background opioid?
- Is the BTP(s) in general of so severe pain intensity that the patient judges he/she needs additional analgesics (apart from background pain analgesics) and does it normally last for more than 15 minutes?
- Does the patient in general while using a stable, fixed-schedule, opioid regimen have at least three BTP episodes per week but no more than four BTP episodes per day?\*
- Has the patient obtained at least partial relief of BTP(s) with his/her usual immediate-release strong opioid, i.e. oral morphine, oxycodone, hydromorphone or transmucosal fentanyl?
- Is the patient able to use intranasal drugs?
- Does the patient use adequate contraceptive precaution (contraceptive pill, implant or injection or intrauterine device) in the trial period?
- Did the patient have a negative pregnancy test at the inclusion in studies FT-016-IM or FT-017-IM?
Exclusion
- All exclusion criteria must be answered "no" for a patient to participate in the trial.
- 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? (Investigator's judgement according to local practice)
- Has the patient had any recent therapy, which could potentially alter pain or response to analgesics to a degree, where the need for background opioid will be less than 60 mg morphine or morphine equivalents/day or less than 25 µg/hour transdermal fentanyl or the number of BTP episodes will be less than three per week during the trial period?
- Has the patient had facial radiotherapy?
- Has the patient been treated with MAO inhibitor within the last 14 days?
- Does the patient use Methadone or Buprenorphine?
- 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 intranasal 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 and participation in intranasal fentanyl trials FT-016-IM/ FT-017-IM within 30 days prior to inclusion in this trial?
- Does the patient have pathological conditions of the nasal cavity as contraindication to intranasal fentanyl?
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00362583
Start Date
June 1 2006
End Date
March 1 2008
Last Update
May 7 2012
Active Locations (1)
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1
Nycomed
Roskilde, Denmark, 4000