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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362583

Enrollment

100

Registered

2006-08-10

Start date

2006-06-30

Completion date

2008-03-31

Last updated

2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer pain with breakthrough pain episodes

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

Interventions

DRUGFentanyl

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026