Moderate to severe chronic pain
Conditions
Interventions
Product Name: divisible buprenorphine transdermal patch, 20 mg
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: buprenorphine
Current Sponsor code: CG5303
Concentration unit: mg/g milligram
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - At least 18 years of age at enrolment - Subjects suffering from chronic non-malignant pain (of at least 3 months duration) - Subjects with pain intensity of at least 5 on an 11-point NRS and requiring an equianalgesic dose range equivalent to 30 - 60 mg oral morphine per day - Subjectsts taking = 325 mg acetylsalicylic acid (ASA) daily for cardiovascular prophylaxis who have been on a stable dose for = 30 days may be enrolled - Males or non-pregnant, non-lactating, or postmenopausal females. Female patients of childbearing potential must use an acceptable method of contraception (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) during study period and have a negative urine pregnancy test (at screening). - Expected course of the disease and the pain that will permit compliance with the study protocol over the entire study period - The patient has been informed about the nature of the study, understood the information and given written informed consent before undergoing any study 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: - Participation in another study parallel to or less than 30 days before study entry - Alcohol and/or drug abuse in the investigator’s judgment, based on patient history and physical examination - Positive urine test for drugs of abuse, other than prescription analgesic substances for a medical condition - Subjects with respiratory depression in the absence of resuscitative equipment, and in patients with severely impaired respiratory centre/function, and in any patient who has or is suspected of having a paralytic ileus - Subjects who are opioid tolerant, or have used opioids for any indication within 3 months of study start, who have ever used opioids for longer than 6 months - Previous and/or current unhealed extensive dermal damage in the area where the patch is to be applied (e.g., dermatitis, burns, scarring of the skin) - Known hypersensitivity to any of the study medications, i.e., the active substance buprenorphine or to any of the excipients - Any scheduled surgery and/or painful procedure during the course of the study - History of seizure disorder, dementia and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin - Intake of adjuvant analgesics (e.g. antidepressants, anticonvulsants, selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], muscle relaxants, bisphosphonates, corticosteroids, phytopharmaceutics), antiparkinsonian drugs, neuroleptics or laxatives if not on a stable dose within 30 days prior to the screening visit - Concomitant intake and/or intake within 30 days prior to the screening visit of monoamine oxidase (MAO) inhibitors or anti-emetics - TENS (transcutaneous electrical nerve stimulation), physiotherapy, acupuncture, and other adjunctive therapy if procedures are not stable, ie, performed at the same ferquency, within 30 days prior to the screening visit - Patients suffering from myasthenia gravis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and tolerability of a titrated divisible buprenorphine transdermal patch in comparison to non-titrated buprenorphine transdermal patch over 4 weeks in opioid naïve patients with moderate to severe chronic non-malignant pain;Secondary Objective: - Incidence of adverse events - Time to withdrawal due to adverse events or lack of efficacy - Frequency and intensity of adverse events - Twice daily assessments of current pain intensity using an 11-point Numerical Rating Scale (NRS). - Twice daily assessments of average pain intensity in the last 24 hours using an 11-point Numerical Rating Scale (NRS). - Amount and frequency of intake of rescue medication - Patient's global evaluation using a 5-point verbal rating scale (VRS) - Sleep questionnaire using the Chronic Pain Sleep Inventory (CPSI);Primary end point(s): The primary endpoint will be a comparison for non inferiority of the titrated divisible buprenorphine transdermal patch versus the buprenorphine transdermal patch Transtec® PRO based on baseline adjusted mean pain intensity at Visit 5 (Day 27-29). Pain in the last 24 hours will be used for evaluation of the primary endpoint. | — |
Countries
Austria, Hungary, United Kingdom
Outcome results
None listed