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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Endo Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01210352
First received: September 17, 2010
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Post Operative Pain
Drug: oxymorphone HCl
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 72
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CII Drug
Open Label
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

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210352

Contacts
Contact: Doris Schmidt 484-216-7434 Schmidt.DorisAnn@Endo.com

  Show 19 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Todd Kirby, PhD Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01210352     History of Changes
Other Study ID Numbers: EN3319-302
Study First Received: September 17, 2010
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
surgical pain
acute pain
Acute Post Surgical Pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Oxymorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on August 20, 2014