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Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children

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ClinicalTrials.gov Identifier: NCT04681027
Recruitment Status : Suspended (Study Suspended 06Feb2020 per FDA Request)
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
The purpose of this study was to assess the safety and pharmacokinetics (single- and multiple-dose) of oxymorphone ER for the relief of moderate to severe pain in pediatric participants ages 7 - ≤17 years old requiring a continuous, around-the-clock (ATC) opioid treatment for an extended period.

Condition or disease Intervention/treatment Phase
Chronic Pain Postsurgical Pain Drug: Oxymorphone hydrochloride (HCl) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study of the Safety, Tolerability, Effectiveness, and Pharmacokinetics of Oxymorphone HCL Extended-Release Tablets in Pediatric Subjects Requiring an Around-The-Clock Opioid for an Extended Period of Time
Actual Study Start Date : March 11, 2013
Actual Primary Completion Date : April 4, 2017
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pediatric Age Groups: 7 to ≤12 years
Participants expected to require ATC opioids for an extended period of time
Drug: Oxymorphone hydrochloride (HCl)
Opioid
Other Name: OPANA® ER (oxymorphone HCl) Extended-Release Tablets

Active Comparator: Pediatric Age Groups: 13 to ≤17 years
Participants expected to require ATC opioids for an extended period of time
Drug: Oxymorphone hydrochloride (HCl)
Opioid
Other Name: OPANA® ER (oxymorphone HCl) Extended-Release Tablets




Primary Outcome Measures :
  1. Pain Intensity Score using FPS-R [ Time Frame: 14 Days Post Last Dose ]
    Faces Pain Scale - Revised (FPS-R) self-report measure used to assess pain intensity in participants ages 7 - ≤12 years old, consists of 6 faces, visually representing increasing changes in pain intensity bounded on the left by "no pain" and on the right by "very much pain".

  2. Pain Intensity Score using NRS-11 [ Time Frame: 14 Days Post Last Dose ]
    Numerical Rating Scale (NRS-11) is an 11-point categorical numerical rating scale to assess pain intensity in participants ages 13 - ≤17 years old. The scale is anchored on the left with "No Pain" and is anchored on the right with "Worst Possible Pain".



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Were males or females 7 - ≤17 years of age. Females of childbearing potential had to 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 menstruating females were considered to be of childbearing potential unless they were biologically sterile or surgically sterile for more than 1 year.
  2. Had chronic pain (malignant and/or nonmalignant) or postsurgical pain expected to require ATC opioid analgesia for up to 12 weeks with at least 10 mg per day oxymorphone ER (approximately equal to 30 mg per day oral MSE).
  3. Had a body weight at least 18 kg.
  4. Were able to swallow oxymorphone ER tablets.
  5. Had laboratory results from within 21 days prior to Baseline available including clinical chemistry and hematology laboratory analytes. Intraoperative (prior to surgical incision) labs were acceptable provided the results had been reviewed by the investigator for study eligibility prior to dosing.
  6. Subjects with postsurgical pain were prescribed a parenteral analgesic regimen utilizing a short-acting opioid analgesic AND were anticipated to be switched to an oral opioid for an extended period of time (according to institutions standard of care).
  7. Were able to provide pain assessment evaluations using age-appropriate instruments provided in the protocol.
  8. Had been informed of the nature of the study and informed consent and assent (as appropriate) have been obtained from the legally responsible parent(s)/legal guardian(s) and subject, respectively, in accordance with IRB requirements.

    To participate in the PK Period, subjects had:

  9. Been hospital inpatients, expected to be hospitalized for up to 72 hours following the initial administration of oxymorphone ER.
  10. An indwelling access catheter in place for blood sampling.

Exclusion Criteria:

  1. Had known allergies or sensitivities to oxymorphone or other opioid analgesics.
  2. Had a known sensitivity to any component of the oxymorphone ER.
  3. Had a life expectancy <3 months.
  4. Was pregnant and/or lactating.
  5. Had cyanotic heart disease.
  6. Had respiratory, hepatic, renal, neurological, psychological disease, or any other clinically significant condition that would, in the Investigator's opinion, preclude participation in the study.
  7. Had abdominal trauma that would interfere with absorption of oxymorphone ER.
  8. Had increased intracranial pressure.
  9. Had a respiratory condition requiring intubation.
  10. Had a history of uncontrolled seizures that were not managed with anticonvulsants.
  11. Had prior history of substance abuse or alcohol abuse.
  12. Had taken a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of oxymorphone ER.
  13. Had taken oxycodone or oxymorphone within 48 hours prior to Baseline.
  14. The investigator anticipated that the subject and/or parent(s)/legal guardian(s) was unable to comply with the protocol.
  15. The subject (and/or parent[s]/legal guardian[s]) was (were) unable to communicate effectively with study personnel.

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): NCT04681027


Locations
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United States, California
Endo Clinical Trial Site #3
Orange, California, United States, 92868
United States, Louisiana
Endo Clinical Trial Site #5
New Orleans, Louisiana, United States, 70112
United States, Oklahoma
Endo Clinical Trial Site #1
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Endo Clinical Trial Site #4
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Endo Clinical Trial Site #2
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Saji Vijayan Endo Pharmaceuticals
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04681027    
Other Study ID Numbers: EN3202-037
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Oxymorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia