Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children
NCT ID: NCT04681027
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
15 participants
INTERVENTIONAL
2013-03-11
2021-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pediatric Age Groups: 7 to ≤12 years
Participants expected to require ATC opioids for an extended period of time
Oxymorphone hydrochloride (HCl)
Opioid
Pediatric Age Groups: 13 to ≤17 years
Participants expected to require ATC opioids for an extended period of time
Oxymorphone hydrochloride (HCl)
Opioid
Interventions
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Oxymorphone hydrochloride (HCl)
Opioid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
7 Years
17 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Saji Vijayan
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Endo Clinical Trial Site #3
Orange, California, United States
Endo Clinical Trial Site #5
New Orleans, Louisiana, United States
Endo Clinical Trial Site #1
Oklahoma City, Oklahoma, United States
Endo Clinical Trial Site #4
Pittsburgh, Pennsylvania, United States
Endo Clinical Trial Site #2
Nashville, Tennessee, United States
Countries
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Other Identifiers
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EN3202-037
Identifier Type: -
Identifier Source: org_study_id