chronic, severe cancer pain inadequately controlled with other analgesics
Conditions
Interventions
Product Name: Novosis Buprenorphin TDS
Product Code: BUP-TDS
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: buprenorphine
CAS Number: 52485-79-7
Concentration unit: µg microgram(s)
Concen
Sponsors
Novosis AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 The patient is able to understand and follow instructions and is able to participate in the study for the entire period Patients must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures. 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: Increasing daily doses of the non-opioid analgesic medication in the last 14 days prior to the start of the study Increasing daily doses of steroids, anticonvulsants and antidepressants in the last 14 days prior to the start of the study and in the course of the study Concomitant intake of any other strong opioids (step 3 WHO-Guidelines) 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 interfere with the pain treatment Women with child-bearing potential who do not apply a medically accepted method of contraception (e.g. hysterectomy, sterilisation, oral contraception) Non-pharmacological pain therapies, e.g. neurolysis, acupuncture, epidural anaesthesia Patients with clinically significant impaired renal function Patients with clinically significant impaired hepatic function Patients with a clinically relevant impairment of respiratory function Pregnancy or lactation Known alcoholism or drug abuse Patients with a known or suspected history of abuse of centrally acting substances Patients with increased intracranial pressure 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 such as a second or third-degree AV block, prolongation of the QRS complex over 120 ms or of the QT / QTc-interval over 450 ms for males.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is to demonstrate that the new buprenorphine transdermal system (BUP-TDS) is therapeutically non-inferior to the reference product, Transtec® (Grünenthal GmbH) in patients with chronic, severe cancer pain inadequately controlled with other analgesics;Secondary Objective: Assessment of the number of responders in each treatment group. Assessment of pain intensity during the day and at night with a 5-point verbal rating scale in each treatment group Assessment of pain in the judgement of the patient with the Brief Pain Inventory Calculation of the mean number of sublingual tablets required as rescue medication per day during the active treatment phase in each treatment group Duration of sleep undisturbed by pain in each treatment group Assessment of safety and tolerability characteristics Assessment of dermal tolerability and adhesive properties of the new BUP-TDS compared with Transtec® ;Primary end point(s): none | — |
Countries
Germany, Hungary
Outcome results
None listed