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Trial · NCT04681027

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

NCT04681027, Phase 3, Suspended, Endo USA Inc., a Keenova Therapeutics Company

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children. Trials, record NCT04681027. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04681027

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children
NCT number
NCT04681027
Status
Suspended
Phases
Phase 3
Enrollment
15 participants, actual
Lead sponsor
Endo USA Inc., a Keenova Therapeutics Company
Conditions
Chronic Pain, Postsurgical Pain
Interventions
Oxymorphone hydrochloride (HCl)
First posted
2020-12-23
Last updated
2020-12-23

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPain Intensity Score using FPS-R14 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".
PrimaryPain Intensity Score using NRS-1114 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".

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04681027

GET https://conductscience.org/api/trials/v1/NCT04681027/registered