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

NCT01429051 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2014-03-26

Study results available
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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.

Conditions

Interventions

DRUG

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.

DRUG

Placebo

Matching intranasal placebo spray

Sponsors & Collaborators

Principal Investigators

  • Medical Director, Clinical Science · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Hungary
  • Norway
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01429051 on ClinicalTrials.gov