Intranasal fentanyl for the treatment of breakthrough pain in cancer patients: a randomised, double-blind, placebo-controlled, cross-over confirmatory trial testing the doses 50, 100 and 200 g fentanyl and placebo in eight break-through pain episodes. - ND
- Conditions
- Breakthrough PainMedDRA version: 6.1Level: PTClassification code 10058019
- Registration Number
- EUCTR2005-002347-82-IT
- Lead Sponsor
- YCOMED HEADQUARTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 175
All inclusion criteria must be answered yes for a patient to participate in the trial. Inclusion criteria at screening 1. 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 2. Is the patient a cancer patient with breakthrough pain 3. Is the patient aged 18 years 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 generally stable and on average controlled to a mild level defined as 8804; 4 on an 11 point NRS by the background pain opioid 7. Is the BTP s in general of so severe pain intensity that the patient judges he/she needs additional analgesics apart from background pain medication and does it normally last for more than 15 minutes 8. 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 9. 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 10. Is the life expectancy of the patient at least 3 months 11. Is the patient able to use intranasal drugs If background pain and/or number of BTP episodes are too high, please continue screening after adjustment of background pain medication. For female patients of childbearing potential Childbearing potential is considered until menopause has lasted more than 12 months. Surgically hysterectomised and surgically successfully sterilised females may be included on the same conditions as male patients . 12. Does the patient use adequate contraceptive precaution contraceptive pill, implant or injection or intrauterine device in the trial period 13. Does the patient have a negative pregnancy test Additional inclusion criteria evaluated before the 200 g NAF test dose at baseline-visit The inclusion criteria 14-16 must apply based on the diary recordings by the patient performed during seven days between screening and baseline visit. Adjustment of background pain opioid followed by diary recording must continue until inclusion criteria 14-16 apply. 14. Was the background 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 background 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
All exclusion criteria must be answered no for a patient to participate in the trial. Exclusion criteria at screening 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 sufficient to compromise data collection 4. Has the patient severe hepatic impairment Investigator s judgement according to local practice 5. Has the patient had any recent therapy, which could potentially alter pain or response to analgesics to a degree, where the need for background pain opioid will be a less than 60 mg morphine or morphine equivalents/day or b 25 g/hour transdermal fentanyl or the number of BTP episodes will be less than three per week during the trial period 6. Has the patient had facial radiotherapy 7. Has the patient been treated with MAO inhibitor within the last 14 days 8. Does the patient use Methadone or Buprenorphine 9. 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 10. Does the patient use drugs for intranasal administration 11. Does the patient have nasopharyngeal probe 12. Is the patient known to be hypersensitive to fentanyl or to other opioids or any of the excipients in the opioids 13. 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 14. Has the patient concomitant participation in any other trial with an investigational drug or device apart from curative cancer treatment and participation in NAF trials FT-016-IM/ FT-017-IM within 30 days prior to inclusion in this trial 15. Does the patient have pathological conditions of the nasal cavity as contraindication to intranasal fentanyl
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method