This study is currently not recruiting participants.

An Open-Label Multicenter Study of the Safety Pharmacokinetics and Efficacy of Buprenorphine Transdermal System (BTDS) in Children from 7 to 16 Years of Age Inclusive Who Require Continuous Opioid Analgesia for Moderate to Severe Pain

Investigating the Safety and Effects of an Investigational Medication in Pediatric Patients

Not Recruiting
7 years - 16 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of the research study is to test the safety (including the side effects for children), efficacy (how well the drug works) and pharmacokinetics (PK - which is what the body does to a drug) of the study drug BTDS.

Detailed description of study

The purpose of the research study is to test the safety (including the side effects for children), efficacy (how well the drug works) and pharmacokinetics (PK - which is what the body does to a drug) of the study drug BTDS.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pain
  • Age: 7 years - 16 years
  • Gender: All

This study investigates the safety, effectiveness, and pharmacokinetics of an investigational medication in children. Safety refers to understanding the side effects that might occur. Effectiveness means how well the investigational medication works. Pharmacokinetics is the study of what the body does to the medication, such as how it absorbs and breaks it down.

Participants in the study will undergo various procedures to assess these aspects. This may include taking the investigational medication and undergoing tests to monitor its effects on the body. The procedures aim to gather comprehensive data on the medication's impact.

  • Who can participate: The study is looking for children who meet specific eligibility criteria for participation. Specific eligibility criteria are not provided.
  • Study details: Participants will receive the investigational medication BTDS and undergo tests to study its effects. A placebo, an inactive substance that looks like the investigational medication but does not contain any medicine, may be used for comparison.
Updated on 19 Feb 2024. Study ID: 1201007906

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