Pharmacokinetics of BTDS in children with severe mouth pain

• Research type

  Research Study

• Full title

  A multi-centre, open-label, single therapy, dose ranging study to characterise the pharmacokinetics and tolerability of BTDS 5-20 ug/h in children who require opioid analgesia for severe mouth pain secondary to chemotherapy induced mucositis.

• Contact name

  Richard Hain

• Sponsor organisation

  Mundipharma Research Limited

• Eudract number

  2008-002428-27

• ISRCTN Number

  n/a

• Research summary

  Giving medicines by applying them to the skin (transdermal route) avoids unpalatable oral medication or subjecting the child to injections or rectal administration. There is an unmet need for a licensed buprenophine transdermal product for children. We believe that the single 7 day patch application pharmacokinetic study in children will provide us with the essential pharmacokinetic (PK) measures that will allow safe dosing in children with moderate to severe pain.Approximately 15 subjects will be recruited in the first phase of the study. The data obtained from these subjects will be reviewed by an IDMC. If the IDMC is satisfied that there are no significant safety concerns then recruitment will continue. Subjects will attend a screening visit which will include recording of blood chemistry values. If they are eligible their study medication (a skin patch) will start at this visit and be in place for 7 days. During this time safety assessments (vital signs, sedation scores, patch site assessment), mucositis scores, pain scores and pharmacokinetic sampling (to determine blood concentrations of buprenorphine) will be carried out each day. Assessment of carbon dioxide levels and oxygen saturation monitoring will be discretionary.A pharmacokinetic sample will be taken prior to patch removal and an additional blood sample (2 mL) will be taken to determine the fraction of drug bound to the plasma protein. Subjects will continue to have pharmacokinetic samples taken daily from Day 9 to 12 and will continue their safety assessments and pain scores. They will be given rescue medication for breakthrough pain throughout the study, as needed.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  08/H0504/179

• Date of REC Opinion

  27 Feb 2009

• REC opinion

  Further Information Favourable Opinion