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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00362583
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : May 7, 2012
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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

Condition or disease Intervention/treatment Phase
Cancer Drug: Fentanyl Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : March 2008

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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 opioid of the patient equivalent to 60-500 mg oral morphine/day or to transdermal fentanyl 25-200 µg/hour? For conversion table.
  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 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 analgesics) 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 patient able to use intranasal drugs?
  11. Does the patient use adequate contraceptive precaution (contraceptive pill, implant or injection or intrauterine device) in the trial period?
  12. Did the patient have a negative pregnancy test at the inclusion in studies FT-016-IM or FT-017-IM?

Exclusion Criteria:

All exclusion criteria must be answered "no" for a patient to participate in the trial.

  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 that may 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 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?
  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 their excipients?
  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 cancer treatment and participation in intranasal fentanyl 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?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00362583

Roskilde, Denmark, 4000
Sponsors and Collaborators
Study Chair: Nycomed Clinical Trial Operations Headquaters

Responsible Party: Nycomed, Clinical Trial Operations Identifier: NCT00362583     History of Changes
Other Study ID Numbers: FT-018-IM
First Posted: August 10, 2006    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Nycomed:
Cancer pain with breakthrough pain episodes

Additional relevant MeSH terms:
Breakthrough Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General