Efficacy and Safety of Intranasal Fentanyl in the Treatment of Breakthrough Pain (FT-018-IM)

NCT00362583 | Completed Phase 3

• 2 other identifiers: FT-018-IM2005-002348-24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 treatment with intranasal fentanyl Secondary objectives: \- To explore the relationship between dose of background opioid treatment and titrated fentanyl dose

Conditions

Cancer

Keywords

Cancer pain with breakthrough pain episodes

Interventions

Fentanyl DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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?
• Does the patient have pathological conditions of the nasal cavity as contraindication to intranasal fentanyl?

Sponsors & Collaborators

• Nycomed: lead

Study Sites (1)

Nycomed

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nycomed Clinical Trial Operations

  Headquaters

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 10, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2008
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

DK (1)