Trials / Completed
CompletedNCT02424578
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
A Phase IIA, Open-Label, Safety and Pharmacokinetic Study of Diclofenac Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Iroko Pharmaceuticals, LLC · Industry
- Sex
- All
- Age
- 6 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to \<17 years experiencing mild to moderate acute postoperative pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Diclofenac Capsules low dose | |
| DRUG | Diclofenac Capsules high dose |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-19
- First posted
- 2015-04-23
- Last updated
- 2017-07-13
- Results posted
- 2017-07-13
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02424578. Inclusion in this directory is not an endorsement.