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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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24 April 2012 |
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Main ID: |
EUCTR2008-001841-24-IT |
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Date of registration:
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13/10/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A European Multicenter Open-Label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
- ND
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Scientific title:
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A European Multicenter Open-Label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
- ND |
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Date of first enrolment:
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19/08/2009 |
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Target sample size:
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1200 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001841-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: - same IMP used at different dosage
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Phase:
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Countries of recruitment
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France
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Germany
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Ireland
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Italy
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Netherlands
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Spain
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
(a) The patient is willing to provide written informed consent to participate in this study. (b) The patient is at least 18 years of age. (c) The patient can be either an out-patient or an in-patient. (d) The patient has a histologically documented diagnosis of cancer (i.e., a solid tumor or hematological malignancy). (e) The patient has stable background pain due to cancer. (f) The patient experiences, on average, up to 4 BTP episodes per 24 hours occurring at the location of the chronic pain, while taking maintenance opioid therapy. (g) As maintenance opioid therapy the patient is currently taking 1 of the following: at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug. (h) Women of childbearing potential, using a medically accepted, highly effective method of birth control and agree to continued use of this method for the duration of the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device, or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. (i) The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, complete the diaries, and attend scheduled study visits as specified in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
(a) The patient is without maintenance opioid therapy, as there is an increased risk of respiratory depression. (b) The patient has uncontrolled or rapidly escalating pain as determined by the investigator (i.e., the maintenance opioid therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug. (c) The patient has known or suspected hypersensitivities, allergies, or other contraindications to the active drug or to any of the excipients of the study drug. (d) The patient has respiratory depression or chronic obstructive pulmonary disease, or any other medical condition predisposing to respiratory depression. (e) The patient has a medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. (f) The patient is expected to have surgery during the study. (g) The patient is pregnant or lactating. (h) The patient has participated in a study involving an investigational drug in the prior 30 days. (i) The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug. (j) The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that could, in the opinion of the investigator, compromise the patient?s safety or compliance with the study protocol, or compromise collected data.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Breakthrough Pain (BTP) in cancer patients
MedDRA version: 9.1
Level: LLT
Classification code 10058019
Term: Cancer pain
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Intervention(s)
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Product Name: Effentora
Pharmaceutical Form: Tablet
INN or Proposed INN: Fentanyl
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Product Name: Effentora
Pharmaceutical Form: Tablet
INN or Proposed INN: Fentanyl
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Product Name: Effentora
Pharmaceutical Form: Tablet
INN or Proposed INN: Fentanyl
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 400-
Product Name: Effentora
Pharmaceutical Form: Tablet
INN or Proposed INN: Fentanyl
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 600-
Product Name: Effentora
Pharmaceutical Form: Tablet
INN or Proposed INN: Fentanyl
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 800-
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Primary Outcome(s)
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Main Objective: The primary objective of the study is to compare the percentage of patients reaching an effective fentanyl buccal tablet (FBT) dose with a starting dose of 100 mcg (Group A) to those with a starting dose of 200 mcg (Group B)
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Primary end point(s): The primary efficacy measure is the number of patients reaching an effective FBT dose with a starting dose of 100 mcg (Group A) or 200 mcg (Group B), as derived from the effective dose assessments in the patients? titration-period diary collected at visit 3.
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Secondary Objective: To evaluate the safety and tolerability of FBT treatment for BTP based on the assessment of adverse events, vital signs, and concomitant medication usage, and oral mucosal and physical examinations (special attention will be directed to the analysis of reasons for patient withdrawals to assess potential cases of misuse as well as for patients under fentanyl based maintenance therapy) - To evaluate the analgesic efficacy of FBT treatment for BTP during the treatment period through the time to reach meaningful pain relief assessed by the patient using a stopwatch, the proportion of episodes in which standard rescue medication was required for relief of BTP and the medication performance, after the administration of study drug - To evaluate the effect of FBT treatment on the patients? quality of life and functional status - To evaluate the patients? global assessment of the FBT treatment for BTP - To assess long-term safety (when applicable)
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Secondary ID(s)
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2008-001841-24-GB
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C25608/4027/BP/EU
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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