Trials / Terminated
TerminatedNCT02687451
Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
An Open-Label Single-Dose And Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of Oxymorphone Hydrochloride (HCl) For Acute Moderate To Severe Postoperative Pain In Pediatric Subjects
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Endo Pharmaceuticals · Industry
- Sex
- All
- Age
- 0 Years – 2 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxymorphone HCl | Oral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC). |
| DRUG | Placebo | Placebo Comparator for the double-blinded, placebo-controlled multiple-dose phase. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2020-07-01
- Completion
- 2020-09-15
- First posted
- 2016-02-22
- Last updated
- 2021-10-26
- Results posted
- 2021-10-26
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02687451. Inclusion in this directory is not an endorsement.