Breakthrough pain related to cancer. MedDRA version: 14.1 Level: LLT Classification code 10069398 Term: Breakthrough cancer pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Product Name: Fentanyl Ethypharm
Product Code: FYL/24019
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: FENTANYL CITRATE
CAS Number: 990-73-8
Other descriptive name: Fentanyl Ethypharm
C
Sponsors
Laboratoires Ethypharm
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: • To assess the safety and tolerability of Fentanyl Ethypharm when used to relieve BTP in opioid-treated cancer patients. • To assess the efficacy of Fentanyl Ethypharm on the neuropathic component of BTP. ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czech Republic
Contacts
Public ContactProject management
ICTA PM
Outcome results
None listed