Efficacy and Safety of Intranasal Fentanyl in the Treatment of Breakthrough Pain (FT-018-IM)
This study has been completed.
Information provided by:
First received: August 9, 2006
Last updated: May 4, 2012
Last verified: May 2012
- 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 treatment with intranasal fentanyl
- To explore the relationship between dose of background opioid treatment and titrated fentanyl dose
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
||A Double-blind, Randomised, Placebo-controlled Trial Confirming the Efficacy of Intranasal Fentanyl Titrated to 50, 100 or 200 µg With an Open Long-term Safety Follow-up in Cancer Patients With Breakthrough Pain
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 80 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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?
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?
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00362583
|Roskilde, Denmark, 4000 |
||Nycomed Clinical Trial Operations
||Nycomed, Clinical Trial Operations
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 9, 2006
||May 4, 2012
||Austria: Federal Ministry for Health and Women
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Ministry of Health
Italy: The Italian Medicines Agency
Poland: Ministry of Health
Keywords provided by Nycomed:
Cancer pain with breakthrough pain episodes
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2016
Nervous System Diseases
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents