DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Cephalon
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breakthrough Pain

Intervention: ACTIQ (Oral transmucosal fentanyl citrate) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cephalon

Summary

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.

Clinical Details

Official title: 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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: to determine if ACTIQ treatment will reduce the number of inadequately managed episodes of breakthrough pain

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Institut Gustave Roussy, Villejuif 94800, France

Centre Se Soins Palliatifs, Alix 69380, France

University Clinics Aachen, Aachen 52074, Germany

University Clinics Aachen, Aachen 52074, Germany

University of Cologne, Cologne 50931, Germany

Knappschaftskrankenhaus Bottro, Bottrop 46242, Germany

University of Sheffield, Sheffield S10 2JF, United Kingdom

King Edward 7th Hospital, Midhurst GU29 0BL, United Kingdom

St Bartholmew┬┐s Hospital, London EC1A 7BE, United Kingdom

Institut Claudius Regaud, Toulouse, Cedex 31052, France

Institut Oscar Lambret, Lille, Cedex 59020, France

St. Claires Hospice, Harlow, Essex CM17 9JX, United Kingdom

Additional Information


Last updated: January 12, 2006

Page last updated: June 20, 2008

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014