Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
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| ClinicalTrials.gov Identifier: NCT01210352 |
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Recruitment Status :
Active, not recruiting
First Posted : September 28, 2010
Last Update Posted : January 17, 2018
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Sponsor:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Endo Pharmaceuticals
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post Operative Pain | Drug: oxymorphone HCl | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 72 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | December 2010 |
| Estimated Primary Completion Date : | February 2018 |
| Estimated Study Completion Date : | February 2018 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: CII Drug
Open Label
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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 |
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 ]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 ]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.
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| Ages Eligible for Study: | 2 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210352
Locations
| United States, Arizona | |
| University of Arizona Medical Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, Colorado | |
| The Children's Hospital | |
| Aurora, Colorado, United States, 80045 | |
| United States, Indiana | |
| Indiana Univeristy School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Tennessee | |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Children's Medical Center Dallas | |
| Dallas, Texas, United States, 75235 | |
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
| Study Director: | Todd Kirby, PhD | Endo Pharmaceuticals |
| Responsible Party: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01210352 History of Changes |
| Other Study ID Numbers: |
EN3319-302 |
| First Posted: | September 28, 2010 Key Record Dates |
| Last Update Posted: | January 17, 2018 |
| Last Verified: | January 2018 |
Keywords provided by Endo Pharmaceuticals:
|
surgical pain acute pain Acute Post Surgical Pain |
Additional relevant MeSH terms:
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Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms Oxymorphone |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia |