A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain (BUP1501)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00947466
Recruitment Status : Terminated (25 patients have been recruited and it was considered that further recruitment would add no extra PK information)
First Posted : July 28, 2009
Last Update Posted : September 28, 2015
Information provided by (Responsible Party):
Mundipharma Research Limited

July 8, 2009
July 28, 2009
September 28, 2015
February 2010
November 2012   (Final data collection date for primary outcome measure)
To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg [ Time Frame: PK's taken daily for 12 days ]
To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg [ Time Frame: every 4 hours to day 5, day 12 and day 21 ]
Complete list of historical versions of study NCT00947466 on Archive Site
safety & tolerability of BTDS 5-20ug/h in children [ Time Frame: every 4 hours to day 5, day 12 and day 21 ]
Same as current
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A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain
A Multi Centre Open Label Single Therapy Dose Ranging Study to Characterise the Pharmacokinetics & Tolerability of BTDS 5-20 ug/h in Children Who Require Opioid Analgesia for Moderate to Severe Mouth Pain Secondary to Chemotherapy Induced Mucositis.
The purpose of this study is to characterize the pharmacokinetics and tolerability of buprenorphine patches in children who require opioid pain relief for moderate to severe mouth pain.
Subjects will be screened for eligibility and if eligible will apply a buprenorphine patch (Day 1). The patch will be worn for 7 days during which time, safety assessments, pain scores, mucositis scores, PK sampling & vital signs will be assessed on each day. After patch removal subjects will continue with these assessments on a daily basis until Day 12. The subject will then be followed up for 10 days (to Day 22) to collect information on ongoing/new SAEs/AEs.
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chemotherapy Induced Mucositis
  • Mouth Pain
Drug: Buprenorphine
Transdermal patch
Experimental: Patch
Intervention: Drug: Buprenorphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Male or female children experiencing 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 'severe' pain in the Investigators clinical judgment.
  3. Body weight ≥ 15 kg. Subjects weighing ≥ 25 kg will be recruited in the first phase of the study with those weighing < 25 kg also being included in the second phase, (after a successful review by an IDSMC). 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.

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 enrollment in this clinical study.
  16. Subjects who the Investigator believes are unsuitable for the study.
Sexes Eligible for Study: All
2 Years to 16 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Denmark,   United Kingdom
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Mundipharma Research Limited
Mundipharma Research Limited
Not Provided
Not Provided
Mundipharma Research Limited
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP