Evaluate the Efficacy and Safety of ACTIQ in Patients With Cancer and Breakthrough Pain

A Randomised, Open-label, Parallel-group Study to Evaluate the Efficacy and Safety of ACTIQ (Oral Transmucosal Fentanyl Citrate) Titrated According to 2 Regimens in Patients With Cancer and Breakthrough Pain

The primary objective of the study is to determine whether a test titration regimen of ACTIQ treatment will reduce the number of inadequately managed episodes of breakthrough pain for an individual patient by attaining a successful dose of ACTIQ treatment more quickly. The successful ACTIQ dose provides a satisfactory combination of efficacy and tolerability after a single administration, as assessed by the patient.

Study Overview

• Status: Completed
• Conditions: Breakthrough Pain
• Intervention / Treatment: Drug: ACTIQ (Oral transmucosal fentanyl citrate)

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Patients are included in the study if all of the following criteria are met:

• the patient is at least 18 years old
• women must be surgically sterile, 2 years postmenopausal, or if of child-bearing potential, must use a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device)
• the patient experiences persistent pain associated with cancer or cancer treatment
• for at least 7 days before enrolment, the patient has taken either the equivalent of 60 to 1000 mg/day of oral morphine around-the-clock (ATC) or 25 to 300 micrograms/hr of transdermal fentanyl to treat persistent pain
• the patient regularly experiences between 1 and 4 episodes of cancer-related BTP per day while taking ATC opioid therapy
• the patient experiences at least partial relief of cancer related BTP by administering conventional opioid BTP medication at a dose approximately in the range of one-fifth to one-sixth the 24-hour sustained release dose
• the patient is capable of self-administering ACTIQ by sucking lozenge, producing sufficient saliva to dissolve the lozenge over 15 minutes, and swallowing the saliva
• a responsible adult caregiver is available to assist the patient in case of emergency if the patient will be taking ACTIQ at home
• the patient willingly provides informed consent to participate in this study

Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met:

• the patient experiences uncontrolled or rapidly escalating pain, as determined by the investigator, such that ATC administration of pain medication might be expected to change between the first and last administrations of ACTIQ.
• the patient has known or suspected hypersensitivities and/or allergies to fentanyl
• the patient has a recent history or current evidence or abuse of alcohol or any other drug substance, licit or collection
• the patient has neurological or psychiatric disease sufficient, in the investigator's opinion, to compromise data collection
• the patient received strontium-89 therapy within 6o days prior to entering the study
• the patient received any other therapy (eg, radiotherapy) within a 1 week period prior to entering the study that, in the investigator's opinion, could alter pain or response to pain medication
• the patient has moderate to severe oral mucositis
• the patient is pregnant, nursing, or is of child-bearing potential or not taking adequate contraceptive measures
• the patient has previously been treated with ACTIQ
• the patient has participated in a trial of an unapproved drug in the previous 8 weeks
• the patient has been diagnosed with either severe respiratory depression or severe obstructive lung conditions
• the patient has used monoamine-oxidase inhibitors (MAOI's) within the 2-week period prior to entering the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
to determine if ACTIQ treatment will reduce the number of inadequately managed episodes of breakthrough pain

Collaborators and Investigators

• Sponsor: Cephalon

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (ACTUAL): August 1, 2005

Study Registration Dates

• First Submitted: October 7, 2005
• First Submitted That Met QC Criteria: October 7, 2005
• First Posted (ESTIMATE): October 12, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): January 29, 2013
• Last Update Submitted That Met QC Criteria: January 28, 2013
• Last Verified: October 1, 2005

More Information

Terms related to this study

• Keywords: breakthrough pain; BTP; Break through pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Breakthrough Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: C8278A/302/ON/MN