Patients with chronic, severe cancer pain requiring strong opioids and inadequately controlled with other analgesics.
Conditions
Interventions
Trade Name: Alorphin
Product Name: BUP-TDS with 72 hours action
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485797
Concentration unit: mg milligram(s)
Conce
Sponsors
Novosis AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.1 Inclusion criteria • The patient is suffering from chronic, severe cancer pain and requires opioid treatment • The patient is aged between 18 and 75 years • The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form 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: • Clinically relevant increasing daily doses of the non-opioid and opioid analgesic medication in the last 14 days prior to the start of the study and in the course of the study • Intake of any other strong opioids (step 3 WHO-Guidelines) in the course of the study • Clinically relevant increasing daily doses of co-analgesics, e.g. steroids, anticonvulsants and antidepressants in the last 14 days prior to the start of the study and in the course of the study • Non-pharmacological pain therapies, e.g. neurolysis, acupuncture, epidural anaesthesia • Planned surgery in the next 30 days or in the last 14 days prior to the start of the study • Any treatment which in the opinion of the responsible physician might have a clinically relevant influence on pain intensity • Patients with clinically significant impaired renal or hepatic function Study Code: BUP/006/C / Protocol Version Number: 4 / 2008/ 11th November Page 26 • Patients with a clinically relevant impairment of respiratory function including presence or history of chronic obstructive lung disorder or any other serious lung disease • Pregnancy or lactation • Women with child-bearing potential who do not apply a medically accepted safe method of contraception (e.g. sterilisation, oral contraception) • Known alcoholism or drug abuse • Patients with a known or suspected history of abuse of centrally acting substances • Patients with increased intracranial pressure including metastases in the CNS which could lead to respiratory depression • Present febrile state and regionally increased body temperature which could lead to increased plasma concentrations of buprenorphine • The subject or his family has a history of non-allergic drug reactions, of a drug allergy, or other allergy, which in the opinion of the responsible physician contraindicates the subject's participation in the study • The subject has a known or suspected personal history or family history of adverse reactions or hypersensitivity to buprenorphine or buprenorphine-like substances • Treatment with monoamine oxidase inhibitors in the last 14 days prior to the start of the active treatment phase • Patients suffering from myasthenia gravis • Significant skin lesions on arms (or other chosen area for patch application) or diffuse skin disease (e.g. diffuse psoriasis or eczema) • Subjects with a medical disorder, condition or history of such that would impair the subject’s ability to participate or complete this study in the opinion of the investigator • Participation in another clinical trial within one month prior to enrolment or during the course of the study • Relevant pathological changes in the ECG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is to demonstrate that the BUP-TDS applied every 96 hours (Treatment group A) is therapeutically non-inferior to BUP-TDS applied every 72 hours (Treatment group B). ;Secondary Objective: Secondary objectives of the study are: • Assessment of pain intensity during the day (8 am to 8 pm) and at night (8 pm to 8 am) with a 11-point numeric rating scale in each treatment group • Calculation of the mean number of sublingual tablets required as rescue medication • Calculation of the mean number of sublingual tablets required as rescue medication per day during the active treatment phase compared with the daily demand during the run-in phase in each treatment group • Duration of sleep undisturbed by pain in each treatment group • Assessment of safety and tolerability characteristics of BUP-TDS by measuring the frequency, severity, and type of adverse event • Assessment of dermal tolerability and adhesive properties of BUP-TDS by the Skin Irritation Score and the Adhesion Score (see Section 14.1 Scoring systems) ;Primary end point(s): To assess and compare the analgesic efficacy and tolerability of a buprenorphine transdermal system in two different application intervals using three different dosages (35, 52.5, or 70 µg/h). Assessment of safety and tolerability characteristics, and assessment of dermal tolerability and adhesive properties of BUP-TDS. | — |
Countries
Bulgaria
Outcome results
None listed