Study placebo controlled to test the efficacy of Fentanyl Ethypharm for the treatment of exacerbated pains.

• Conditions: Breakthrough pain related to cancer.; MedDRA version: 14.1Level: LLTClassification code 10069398Term: Breakthrough cancer painSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001140-30-CZ
• Lead Sponsor: aboratoires Ethypharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-25
• Last Update Posted: 7 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1.Written informed consent form obtained;
2.Is at least 18 years of age;
3.Has a documented diagnosis of a malignant solid tumor or a hematological malignancy causing cancer-related pain;
4.Has an Eastern Cooperative Oncology Group (ECOG) performance status rating ?3;
5.Has a life-expectancy of at least 2 months;
6.Has been receiving between 60 mg and 1000 mg of oral morphine daily, or at least 25 µg/hour of transdermal fentanyl or at least 30 mg of oxycodone daily, or 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for cancer-related pain at a stable dose for at least a week;
7.Has a stable background pain intensity =4/10 in the pain scale for at least a week;
8.Experiencing on average, 1 to 4 episodes of breakthrough pain per day that are adequately controlled with a stable dose of standard rescue medication, of which the patient will have an adequate supply throughout the study;
9.Is willing and able (personally or with the help of a caregiver) to:
a.Evaluate and record pain intensity and pain relief and,
b.Record adverse events and,
c.Record each intake of study drug and rescue medication in a patient’s diary and,
d.Return diaries and study drugs at each visit
10.If female of childbearing potential (i.e. not surgically sterile or ?1 year after the onset of amenorrhea due to menopause):
a.Has a negative urinary pregnancy test and,
b.Is not breastfeeding and,
c.Agrees to practice a reliable form of contraception or abstinence during the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Hypersensitivity to fentanyl or to any of the excipients;
2.Is using intrathecal opioids;
3.Has recent history of substance abuse or neurologic or psychiatric impairment that would compromised data collection;
4.Has had recent therapy (within 30 days) or will receive a planned therapy during the study that would alter pain or response to analgesics during the study such as palliative radiation therapy or a nerve block;
5.Has a known moderate or severe hepatic or renal disease*;
6.Has received any other investigational new drug within 30 days before the first study drug administration;
7.Has sleep apnea or active brain metastases with increase intracranial pressure;
8.Is at risk of increased opioid side effects because of prior or concomitant medications (such as CYP3A4 inhibitors, partial opioid agonists/antagonists);
9.Is at risk of significant bradyarrythmia because of underlying heart disease;
10.Has primary source breakthrough pain that is not cancer related;
11.Treated by Mono Amine Oxydase Inhibitor (MAOI), or last MAOI intake within last 2 weeks;
12.Has a severe chronic obstructive pulmonary disease or severe respiratory depression.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: is to assess the clinical effectiveness of Fentanyl Ethypharm when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.;Secondary Objective: are: <br>• To assess the safety and tolerability of Fentanyl Ethypharm when used to relieve BTP in opioid-treated cancer patients.<br>• To assess the efficacy of Fentanyl Ethypharm on the neuropathic component of BTP.<br>;Primary end point(s): The Pain Intensity (PI) will be measured with an eleven-point numerical pain rating scale (0=no pain and 10=worst pain).;Timepoint(s) of evaluation of this end point: Patients will be rated their PI immediately prior to the administration of IMP and at 3, 6, 10, 15, 30 and 60 minutes post-dose.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain Relief (PR) will be measured with a five-point numerical rating scale (0=none; 1=slight; 2=moderate; 3=a lot; 4=complete).;Timepoint(s) of evaluation of this end point: This outcome will be assessed at 3, 6, 10, 15, 30 and 60 minutes after administration of each intake of IMP