Skip to content

A Study to Look at Tapentadol Tablets in Children and Adolescents in Pain

CompletedPhase 2, Phase 3NCT02151682
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Tapentadol has already been studied in adults. This study is needed to find out if tapentadol works and is safe to use in children and adolescents with long-term pain.

Study details

Official title
An Open-label Trial, Enrolling Subjects Aged 6 Years to Less Than 18 Years Suffering From Pain Requiring Prolonged Release Opioid Treatment, to Evaluate the Safety and Efficacy of Tapentadol PR Versus Morphine PR, Followed by an Open-label Extension
Conditions
Interventions
Sponsor
Grünenthal GmbH
Start date
2015-04-29
Primary completion
2017-10-18
Sex
All
Age range
from 6 Years to 17 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Belgium, Bulgaria, Chile, France, Germany, Hungary, Italy, Portugal, Spain, United Kingdom
Total sites listed
23

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Part 1 - Randomized to open-label, active comparator controlled treatment Participants were eligible for the study at enrollment if all the following applied: * Informed consent (if applicable assent) obtained. * Male or female participant at least 6 years of age at the Enrollment Visit and less than 18 years of age on Day 14. * Participant has an underlying long-term pain condition (e.g., cancer, chronic disease, planned or performed surgery) that is, according to the judgment of the investigator, expected to require a twice-daily prolonged release opioid treatment until at least the end of the 14-day Treatment Period. * Participant can swallow tablets of appropriate size. * Participant is able to participate in the study as planned and willing to comply with the requirements of the protocol including refraining from drinking beverages containing alcohol and recreational intake of drugs while on study medication. Participants had to satisfy the following criteria before allocation to treatment: * Less than 18 years of age. * No opioid intake or last calculated morphine equivalent dose of less than 3.5 mg/kg per day. * Participant has a body weight of at least 17.5 kg. * If a female of childbearing potential (post menarchal and not surgically incapable of childbearing) and sexually active, must practice an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch) before allocation to study medication until the end of intake of study medication. * If a female and post menarchal or older than 12 years, has a negative urine pregnancy test on the day before or on the day of allocation to study medication. Part 2 Inclusion criteria for the Tapentadol Open-label extension period: * Participant has completed the 14-day Treatment Period. * Participant is still in need of prolonged release opioid treatment. * Participant does not meet any of the compulsory discontinuation criteria. Exclusion Criteria: Participants were not eligible for the study if any of the following applied. The following was checked at enrollment: * Has been previously enrolled in this study or a previous study with tapentadol. * Has a clinically relevant history of hypersensitivity, allergy, or contraindication to morphine or tapentadol or any ingredient, including galactose intolerance (see investigator's brochure for tapentadol prolonged-release \[PR\] and summary o…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02151682