Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

Tracking Information
First Submitted Date ICMJE	September 17, 2010
First Posted Date ICMJE	September 28, 2010
Last Update Posted Date	August 16, 2018
Study Start Date ICMJE	December 2010
Actual Primary Completion Date	February 12, 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 13, 2013)	Assessment of safety and tolerability will be based on the incidence of Adverse Events(AEs), AEs resulting in discontinuation and serious adverse events [ Time Frame: Safety = Up to 48 hours ]; Single Dose (pain assessment) Effectiveness = baseline, .25. .5. 1. 1.5. 2, 4, 6, 8, 12, 24 post dose; Multi-Dose (pain assessment) Effectiveness= baseline, .5, 1, 1.5, and 2 hrs post dose 1; and immediately prior to all remaining doses administered up through 48 hrs.
Original Primary Outcome Measures ICMJE; (submitted: September 27, 2010)	The pain intensity difference at each post-dose time point will be calculated as the pain intensity score at baseline minus the current pain intensity score at each post-dose time point [ Time Frame: Baseline, 15min, 30min, 1 h, 2h, 3h, 4h, 6h, 8h, 12h or rescue ]; Assessment of safety and tolerability will be based on the incidence of Adverse Events(AEs), AEs resulting in discontinuation and serious adverse events [ Time Frame: Up to 48 hours ]
Change History	Complete list of historical versions of study NCT01210352 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 13, 2013)	To determine and report the the pharmacokinetic profile of oxymorphone IR oral liquid in pediatric subjects in order to determine appropriate dosing recommendations. [ Time Frame: Up to 48 Hours ]; Single-Dose PK: baseline, .25, .5, 1, 1.5, 2, 4, 6, 8, 12, & 24 hrs; Multi-Dose PK = baseline, .5, 1, 1.5, and 2 hrs post dose 1; immediately prior to doses 2, 3, 4, 5, 6, 7; and at .5, 1, 1.5 and 2 hrs post Dose 7.
Original Secondary Outcome Measures ICMJE; (submitted: September 27, 2010)	To determine and report the the pharmacokinetic profile of oxymorphone IR oral liquid in pediatric subjects in order to determine appropriate dosing recommendations. [ Time Frame: Up to 48 hours ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
Official Title ICMJE	An Open-Label, Non-randomized, Multicenter, Ascending Dose by Age, Single- and Multiple-Dose Evaluation of the Effectiveness, Safety, and Tolerability of Oral Liquid Oxymorphone HCl Immediate-Release Oral Liquid for Acute Postoperative Pain in Pediatric Subjects
Brief Summary	The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain in pediatric subjects.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Post Operative Pain
Intervention ICMJE	Drug: oxymorphone HCl; Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone; Other Name: Opana
Study Arms	Experimental: CII Drug; Open Label; Intervention: Drug: oxymorphone HCl
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 15, 2018)	79
Original Estimated Enrollment ICMJE; (submitted: September 27, 2010)	144
Actual Study Completion Date	February 12, 2018
Actual Primary Completion Date	February 12, 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Males or females between 2 to ≤12 years of age. Females of child-bearing potential must be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, all peri- and post-pubertal females will be considered to be of child-bearing potential unless they are biologically sterile or surgically sterile for more than 1 year; Subjects must be at least 10 kg and BMI ≤30; Scheduled to have a surgery for which oral opioid analgesia will be needed to manage postoperative pain for at least 24 hours (Single-Dose Phase) or 48 hours (Multiple-Dose Phase)following intraoperative and/or postoperative parenteral analgesia; Be hospital inpatients, expected to be hospitalized for at least 24 hours (Single-Dose Phase) and 48 hours (Multiple-Dose Phase) following the initial administration of oxymorphone immediate release; Available lab results, either intraoperatively (prior to surgical incision) or from within 21 days preoperatively, for clinical chemistry and hematology laboratory analytes (the results must have been reviewed by the Investigator for study eligibility); Able to provide pain assessment evaluations using an age-appropriate instrument provided in the protocol; On an intravenous analgesic regimen utilizing a short-acting opioid analgesic following surgery AND anticipated to be switched to an oral opioid as part of the analgesic regimen (according to institution SOC); Demonstrated the ability to tolerate clear fluids following surgery according to the SOC at each institution; Informed of the nature of the study and written informed consent has been obtained from the legally responsible parent(s)/legal guardian(s); Provided assent in accordance with IRB requirements; Line in place for blood sampling Exclusion Criteria: Known allergies or sensitivities to oxymorphone or other opioid analgesics; Known sensitivity to any component of the study drug; Life expectancy <4 weeks; Positive pregnancy test at screening (females of reproductive age only); Pregnant and/or lactating; Cyanotic heart disease; Respiratory, hepatic, renal, neurological, psychological disease, or any other clinically significant condition that would, in the Investigator's opinion, preclude participation in the study; Preoperative opioids administered for a period of more than 72 hours in duration; Abdominal trauma that would interfere with absorption of study drug; Increased intracranial pressure; Respiratory condition requiring intubation; History of uncontrolled seizures that are not being managed with anticonvulsants; Significant prior history of substance abuse or alcohol abuse; Received any investigational drug within 30 days prior to the first dose of study drug, or are scheduled to receive an investigational drug other than oxymorphone HCl immediate-release oral liquid during the course of the study; Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study drug; Received oxycodone or oxymorphone within 48 hours prior to study start; Investigator anticipates that the subject and/or parent(s)/legal guardian(s) would be unable to comply with the protocol; Subject (and/or parent[s]/legal guardian[s]) is(are) unable to communicate effectively with study personnel at an age-appropriate level
Sex/Gender	Sexes Eligible for Study: All
Ages	2 Years to 12 Years (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01210352
Other Study ID Numbers ICMJE	EN3319-302
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Endo Pharmaceuticals
Study Sponsor ICMJE	Endo Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Todd Kirby, PhD Endo Pharmaceuticals
PRS Account	Endo Pharmaceuticals
Verification Date	July 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP