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NCT02680847 · ClinicalTrials.gov registry record · Phase 4

Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain

A Phase 4 study, sponsored by Pfizer.

Terminated
Registry status
Phase 4
Development phase
32
Enrollment target

NCT02680847: Clinical Trial Phase 4 study, sponsored by Pfizer.

NCT02680847 is a Phase 4 study that was terminated before completion, run by Pfizer. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02680847, a Phase 4 study, was terminated before completion, sponsored by Pfizer.

TERMINATED
Registry status
Phase 4
Development phase
32 participants
Enrollment target

Study Summary

Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.

Primary Outcome

ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

Interventions

  • DRUG ALO-02

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2016-01-21
Est. Completion 2018-01-24
Phase Phase 4
Pfizer

1,845 total trials

Why NCT02680847 stopped before completion

NCT02680847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which ALO-02 is the first listed.

NCT02680847 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02680847 about?

NCT02680847 is a clinical study titled "Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain". Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.

What is the current status of trial NCT02680847?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2016-01-21. Estimated completion is 2018-01-24.

What interventions are being tested in trial NCT02680847?

The interventions under investigation include: ALO-02 (DRUG).

Who is sponsoring clinical trial NCT02680847?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02680847's enrollment target sits among peer trials

32 1534th of 2000 higher than 457 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02680847, the US trial registry maintained by the National Library of Medicine. NCT02680847 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.