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A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain

NCT02081391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2020-01-18

Study results available
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Summary

The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product (IMP) in children and adolescents who had undergone surgery that would produce moderate to severe pain during opioid treatment.

Conditions

  • Acute Pain

Interventions

DRUG

Tapentadol oral solution 4 mg/mL

Participants aged 6 months to less than 18 years old with a body weight below 20 kg received tapentadol oral solution 4 mg/mL by mouth every 4 hours for up to 72 hours. Participants from birth to less than 6 months received tapentadol oral solution, diluted 4 fold.

DRUG

Tapentadol oral solution 20 mg/mL

Participants aged from 6 months to less than 18 years with a body weight greater than or equal to 20 kg received tapentadol oral solution 20 mg/mL by mouth every 4 hours for up to 72 hours.

OTHER

Placebo

Matching placebo oral solution was administered by mouth every 4 hours up to 72 hours.

Sponsors & Collaborators

  • Depomed

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-19
Primary Completion
2019-03-03
Completion
2019-03-14
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02081391 on ClinicalTrials.gov