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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01210352
First Posted: September 28, 2010
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Endo Pharmaceuticals
September 17, 2010
September 28, 2010
October 18, 2017
December 2010
December 2017   (Final data collection date for primary outcome measure)
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.
  • 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 ]
Complete list of historical versions of study NCT01210352 on ClinicalTrials.gov Archive Site
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.
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 ]
Not Provided
Not Provided
 
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Post Operative Pain
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
Experimental: CII Drug
Open Label
Intervention: Drug: oxymorphone HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
December 2017
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. Subjects must be at least 10 kg and BMI ≤30
  3. 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
  4. 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
  5. 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)
  6. Able to provide pain assessment evaluations using an age-appropriate instrument provided in the protocol
  7. 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)
  8. Demonstrated the ability to tolerate clear fluids following surgery according to the SOC at each institution
  9. Informed of the nature of the study and written informed consent has been obtained from the legally responsible parent(s)/legal guardian(s)
  10. Provided assent in accordance with IRB requirements
  11. Line in place for blood sampling

Exclusion Criteria:

  1. Known allergies or sensitivities to oxymorphone or other opioid analgesics
  2. Known sensitivity to any component of the study drug
  3. Life expectancy <4 weeks
  4. Positive pregnancy test at screening (females of reproductive age only)
  5. Pregnant and/or lactating
  6. Cyanotic heart disease
  7. Respiratory, hepatic, renal, neurological, psychological disease, or any other clinically significant condition that would, in the Investigator's opinion, preclude participation in the study
  8. Preoperative opioids administered for a period of more than 72 hours in duration
  9. Abdominal trauma that would interfere with absorption of study drug
  10. Increased intracranial pressure
  11. Respiratory condition requiring intubation
  12. History of uncontrolled seizures that are not being managed with anticonvulsants
  13. Significant prior history of substance abuse or alcohol abuse
  14. 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
  15. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study drug
  16. Received oxycodone or oxymorphone within 48 hours prior to study start
  17. Investigator anticipates that the subject and/or parent(s)/legal guardian(s) would be unable to comply with the protocol
  18. Subject (and/or parent[s]/legal guardian[s]) is(are) unable to communicate effectively with study personnel at an age-appropriate level
Sexes Eligible for Study: All
2 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01210352
EN3319-302
Yes
Not Provided
Not Provided
Endo Pharmaceuticals
Endo Pharmaceuticals
Not Provided
Study Director: Todd Kirby, PhD Endo Pharmaceuticals
Endo Pharmaceuticals
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP