A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
Public ClinicalTrials.gov record NCT02081391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Evaluation of the Efficacy and Safety of Tapentadol Oral Solution in the Treatment of Post-operative Acute Pain Requiring Opioid Treatment in Pediatric Subjects Aged From Birth to Less Than 18 Years Old
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02081391
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 216 participants
Conditions and interventions
Conditions
Interventions
- Tapentadol oral solution 4 mg/mL Drug
- Tapentadol oral solution 20 mg/mL Drug
- Placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 1 Day to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 19, 2015 (Actual)
- Primary completion
- Mar 3, 2019 (Actual)
- Completion
- Mar 14, 2019 (Actual)
- Last update posted
- Jan 18, 2020
2015 – 2019
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| US008 | Little Rock | Arkansas | 72202 | — |
| US004 | Stanford | California | 94305 | — |
| US011 | Miami | Florida | 33136 | — |
| US012 | Louisville | Kentucky | 40202 | — |
| US001 | The Bronx | New York | 10461 | — |
| US018 | The Bronx | New York | 10467 | — |
| US006 | Durham | North Carolina | 27710 | — |
| US016 | Cincinnati | Ohio | 45229 | — |
| US015 | Philadelphia | Pennsylvania | 19104 | — |
| US014 | Pittsburgh | Pennsylvania | 15224 | — |
| US003 | Dallas | Texas | 75235 | — |
| US005 | Houston | Texas | 77030 | — |
| US007 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02081391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 18, 2020 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02081391 live on ClinicalTrials.gov.