A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain

NCT ID: NCT01429051

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-01-31

Brief Summary

The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.

Detailed Description

This is a clinical trial with 12 weeks treatment of Intranasal fentanyl (INFS) in cancer patients with breakthrough pain (BTP). It was composed of a dose titrated, placebo-controlled, double-blind, randomised, cross-over efficacy phase, combined with a titration and a tolerability phase assessing the safety and nasal tolerability of INFS. The trial is set up with a screening period and three treatment phases: a titration phase (I), an efficacy phase (II) and a tolerability phase (III). The entire trial period for each completed patient consisted of the one week screening period and 12 weeks treatment with INFS.

Conditions

Break Through Pain; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intranasal Fentanyl Spray (INFS)

All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.

Group Type: EXPERIMENTAL

Intranasal Fentanyl Spray (INFS)

Intervention Type: DRUG

Applied as 1 puff (= 1 dose) in one nostril, or applied as two puffs (= 2 doses, 1 in each nostril) with ten minutes apart.

Placebo

Intervention Type: DRUG

Matching intranasal placebo spray

Interventions

Intranasal Fentanyl Spray (INFS)

Applied as 1 puff (= 1 dose) in one nostril, or applied as two puffs (= 2 doses, 1 in each nostril) with ten minutes apart.

Intervention Type: DRUG

Placebo

Matching intranasal placebo spray

Intervention Type: DRUG

Other Intervention Names

Instanyl®

Eligibility Criteria

Inclusion Criteria

• Is the patient a cancer patient with breakthrough Pain (BTP)?
• Has the patient received either oral opioids or transdermal fentanyl for treatment of background pain (BGP) within the last month prior to the screening visit?
• Is the current dose of prescribed opioids (for BGP) equivalent to 60-1000 mg oral morphine/day?
• Has the patient's BGP for the last 7 days prior to the screening visit been generally stable, and on average controlled to a mild level (defined as ≤ 4 on the 11-point Numerical Rating Scale [NRS])?
• Does the patient (at the time of the screening visit) experience his/her current BTP episodes to be of such severe pain intensity, that he/she in general needs additional analgesia (i.e. on top of the background opioid treatment)?
• Has the patient on average for the last 7 days prior to the screening visit had at least three BTP episodes per week, but no more than four BTP episodes per day?
• Is the patient able to use intranasal drugs?
• Is the life expectancy of the patient at least 3 months from the date of the screening visit?

Exclusion Criteria

1. Has the patient had an illicit substance abuse within the last year prior to screening?

2. Does the patient have severe hepatic impairment? - defined as alanine aminotransferase (ALT or) aspartate aminotransferase (AST) levels > 3x upper limit of normal (ULN)

3. Does the patient have severe renal impairment? - defined as serum creatinine ≥ 3.0 mg/dl (265 micromol/L)

4. Has the patient ever had facial radiotherapy or is the patient scheduled to facial radiotherapy?

5. Has the patient been treated with any monoamine oxidase (MAO) inhibitors within the last 14 days prior to the screening visit?

6. Does the patient have severe impaired respiratory function, which may increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment?

7. Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients?

8. Does the patient have any head injury, primary brain tumor or other pathological conditions, which could significantly increase the risk of increased intracranial pressure or impaired consciousness?

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director, Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Budapest, , Hungary

Debrecen, , Hungary

Kazincbarcika, , Hungary

Nyíregyháza, , Hungary

Pécs, , Hungary

Drammen, , Norway

Trondheim, , Norway

Moscow, , Russia

Saint Petersburg, , Russia

Smolensk, , Russia

Yaroslavl, , Russia

Countries

Hungary; Norway; Russia

References

Thronaes M, Popper L, Eeg M, Jaatun E, Kvitberg M, Kaasa S. Efficacy and tolerability of intranasal fentanyl spray in cancer patients with breakthrough pain. Clin Ther. 2015 Mar 1;37(3):585-96. doi: 10.1016/j.clinthera.2014.12.010. Epub 2015 Jan 30.

Reference Type: DERIVED

PMID: 25641199 (View on PubMed)

Other Identifiers

2010-021096-85

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1133-6364

Identifier Type: REGISTRY

Identifier Source: secondary_id

2011/776

Identifier Type: REGISTRY

Identifier Source: secondary_id

FT-1301-032-SP

Identifier Type: -

Identifier Source: org_study_id