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 µg fentanyl and placebo in eight break-through pain episodes
- Conditions
- Breakthrough PainMedDRA version: 8.1Level: PTClassification code 10064556
- Registration Number
- EUCTR2005-002347-82-DK
- Lead Sponsor
- ycomed Danmark ApS
- 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 µg/hour?
6. 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 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 µg 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 µg/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 Objective: - To explore the relationship between the response to the NAF dose and the stable background pain opioid dose;Primary end point(s): The primary efficacy endpoint is the Pain Intensity Difference at 10 min, PID10. ;Main Objective: - To demonstrate efficacy of NAF in the treatment of BTP in cancer patients
- Secondary Outcome Measures
Name Time Method