EUCTR2008-002428-27-GBActive, not recruitingPhase 1
A multi-centre, open-label, single therapy, dose ranging study to characterise the pharmacokinetics and tolerability of BTDS 5-20 µg/h in children who require opioid analgesia for moderate to severe mouth pain secondary to chemotherapy induced mucositis
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Mundipharma Research Limited
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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
- •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.
Investigators
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