Cancer break-through pain MedDRA version: 9.1 Level: LLT Classification code 10058019 Term: Cancer pain
Conditions
Interventions
Product Code: AD 923
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: FENTANYL
CAS Number: 437387
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pr
Sponsors
Sosei R&D Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject met all eligibility criteria for Protocol P AD923 004 or Protocol P AD923 005. The subject continues to take stable around-the-clock opioid therapy for chronic cancer pain, and continues to require therapy for episodes of BTP. The minimum dose of background opioid therapy should be 60 mg/day of morphine or morphine equivalent or 25 µg/hour transdermal fentanyl. If female of childbearing potential, the subject has a negative urine pregnancy test. To be considered not of childbearing potential, the subject must be postmenopausal for at least 2 years, have had a hysterectomy or bilateral tubal ligation with resection, or be otherwise incapable of pregnancy. The subject must agree to continue practicing one of the following methods of contraception consistently: hormonal contraceptives, intrauterine device, spermicide and barrier, spousal/partner sterility, or is practicing abstinence and agrees to continue abstinence or to use an acceptable method of contraception from the above list if sexual activity commences. The subject is able and willing to understand the study and cooperate with the study instructions. The subject is able and willing to provide written informed consent. The subject has a life expectancy of at least 2 months. The subject or his or her caregiver must have easy, reliable access to a telephone. 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
Exclusion criteria: The subject is a female who is pregnant or lactating. The subject has developed any respiratory or cardiac condition that may be worsened by opiates. The subject has developed any allergy to the product excipients, namely, fentanyl, ethanol, menthol, or saccharin. The subject has developed any neurologic or psychiatric disease that, in the opinion of the investigator, would compromise data collection. The subject has begun to abuse alcohol or other substance(s). The subject has hepatic dysfunction as shown by alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) levels elevated more than 5 times the upper limit of normal. The subject has renal dysfunction as shown by creatinine elevated more than 1.5 times the upper limit of normal. The subject has any other clinically significant abnormality in the laboratory tests that, in the opinion of the investigator, will compromise the conduct of the study. The subject has uncontrolled infection. The subject is taking intrathecal or epidural forms of opioids. The subject is taking any prohibited medications as described in the concomitant medications section of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of AD 923 in the treatment of cancer BTP in subjects with malignancies who have participated in either Protocol P-AD923-004 or P-AD923-005;Secondary Objective: To assess the efficacy of AD 923 treatment of cancer BTP in subjects with malignancies who have participated in either Protocol P-AD923-004 or P-AD923-005;Primary end point(s): The primary endpoint is an assessment of safety (Adverse events, withdrawal due to AEs, AD 923 dose reduction because of AEs, clinical laboratory results, 12 lead electrocardiograms (ECGs), physical examination, including vital signs) | — |
Countries
Austria, Hungary, Netherlands, Spain, United Kingdom
Outcome results
None listed