Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents
Public ClinicalTrials.gov record NCT01134536. 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
Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.
Study identification
- NCT ID
- NCT01134536
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 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
- Oct 2011 (Type not available)
- Primary completion
- Mar 2013 (Actual)
- Completion
- Mar 2013 (Actual)
- Last update posted
- Jul 14, 2014
2011 – 2013
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Meridian | Idaho | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | The Bronx | New York | — | — |
| Not listed | Charlotte | North Carolina | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Toledo | Ohio | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Salt Lake City | Utah | — | — |
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 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01134536, 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 Jul 14, 2014 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01134536 live on ClinicalTrials.gov.