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

This study has been terminated.
(25 patients have been recruited and it was considered that further recruitment would add no extra PK information)
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited
ClinicalTrials.gov Identifier:
NCT00947466
First received: July 8, 2009
Last updated: February 21, 2014
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Chemotherapy Induced Mucositis
Mouth Pain
Drug: Buprenorphine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Mundipharma Research Limited:

Primary Outcome Measures:
  • To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg [ Time Frame: PK's taken daily for 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety & tolerability of BTDS 5-20ug/h in children [ Time Frame: every 4 hours to day 5, day 12 and day 21 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patch Drug: Buprenorphine
Transdermal patch

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947466

Locations
Denmark
Skejby, Denmark
United Kingdom
Dr Howell
Liverpool, United Kingdom
Sponsors and Collaborators
Mundipharma Research Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT00947466     History of Changes
Other Study ID Numbers: BUP1501, 2008-002428-27
Study First Received: July 8, 2009
Last Updated: February 21, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency

Keywords provided by Mundipharma Research Limited:
Buprenorphine transdermal patch (BTDS)
Moderate to severe mouth pain
Chemotherapy induced mucositis
Pharmacokinetic

Additional relevant MeSH terms:
Mucositis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014