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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 : October 24, 2018
Information provided by (Responsible Party):
Mundipharma Research Limited

Brief Summary:
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 or disease Intervention/treatment Phase
Chemotherapy Induced Mucositis Mouth Pain Drug: Buprenorphine Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : February 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Patch Drug: Buprenorphine
Transdermal patch

Primary Outcome Measures :
  1. To characterise the pharmacokinetics of BTDS 5-20 ug/h in children weighing >15kg [ Time Frame: PK's taken daily for 12 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00947466

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Skejby, Denmark
United Kingdom
Dr Howell
Liverpool, United Kingdom
Sponsors and Collaborators
Mundipharma Research Limited
Additional Information:
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Responsible Party: Mundipharma Research Limited Identifier: NCT00947466    
Other Study ID Numbers: BUP1501
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Keywords provided by Mundipharma Research Limited:
Buprenorphine transdermal patch (BTDS)
Moderate to severe mouth pain
Chemotherapy induced mucositis
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists