Moderate to severe mouth pain secondary to chemotherapy induced mucositis requiring opioid analgesic therapy.
Conditions
Interventions
Trade Name: BuTrans 5 µg/h transdermal patch
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Buprenorphine
CAS Number: 52485797
Sponsors
Mundipharma Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female children experiencing moderate to severe mouth pain secondary to chemotherapy induced mucositis requiring opioid analgesic therapy and who will be an inpatient, as a minimum up to Day 8 (patch removal) 2. Subjects experiencing ‘moderate to severe’ pain in the Investigators clinical judgment 3. Body weight = 12kg. Subjects aged = 2 years. Upper age range to be 16 years. 4. In dwelling IV cannula or central line from which blood can be obtained 5. Written informed consent obtained from parent(s)/legal representative, and where possible assent obtained from the subject if appropriate, in line with local regulations. 6. Females of child bearing potential must have a negative urine pregnancy test if the Principal Investigator considers there to be a reasonable possibility of pregnancy. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to buprenorphine or any of its excipients in the transdermal system, as outlined in the Summary of Product Characteristics for BuTrans 2. Known hypersensitivity to other opioids 3. Skin disease affecting application or local tolerance of BTDS 4. Clinically significant history of allergic reaction to wound dressings or adhesives 5. Severe respiratory impairment 6. Clinically significant hepatic dysfunction 7. Severe renal impairment 8. Subjects who are receiving MAO inhibitors or have taken them within the previous 2 weeks 9. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator’s opinion, may pose a risk of additional CNS depression with study medication 10. Subjects who have taken any buprenorphine preparations in the last 14 days 11. Subjects with myasthenia gravis 12. Subjects with convulsive disorders, head injury, shock, or reduced level of consciousness of uncertain origin 13. Subjects who are currently participating in another clinical research study involving a new chemical entity (NCE) unless the sole purpose of the other trial at the time of BUP1501 screening is for long term follow-up/survival data or subjects who have participated in a clinical study within the previous 30 days. Participation in a chemotherapy clinical trial that is not evaluating a NCE will be accepted for inclusion 14. Subjects who are pregnant, lactating or in the Investigators opinion are at risk of conceiving 15. Previous enrolment in this clinical study 16. Subjects who the Investigator believes are unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective of main interest: To characterise the pharmacokinetics of BTDS 5-20 g/h in children weighing =12 kg. ; Secondary Objective: Further Objectives: To evaluate the safety and tolerability of BTDS 5-20 g/h in children weighing =12 kg. To compare the pain scores recorded during the study to the pharmacokinetic profiles of buprenorphine and metabolites. To compare the exposures in the different weight groups and also to compare this to historic data in adults. ;Primary end point(s): | — |
Countries
Denmark, United Kingdom
Outcome results
None listed