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NCT01115569 · ClinicalTrials.gov registry record · Phase 3

Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

A Phase 3 study, sponsored by Zogenix.

Completed
Registry status
Phase 3
Development phase
424
Enrollment target

NCT01115569 is a Phase 3 study that has completed, run by Zogenix. The registered enrollment target is 424 participants.

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The verdict

NCT01115569, a Phase 3 study, has completed, sponsored by Zogenix.

COMPLETED
Registry status
Phase 3
Development phase
424 participants
Enrollment target

Study Summary

This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

Interventions

  • DRUG Hydrocodone Bitartrate

Trial Details

FieldValue
Enrollment Target 424 participants
Start Date 2010-05
Est. Completion 2012-01
Phase Phase 3

Sponsor

Zogenix

9 total trials

What the Registry Record Tells You About NCT01115569

The ClinicalTrials.gov registry entry for NCT01115569 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zogenix, which has 9 total studies on file at ClinicalTrials.gov.

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

NCT01115569 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01115569 about?

NCT01115569 is a clinical study titled "Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain". This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

What is the current status of trial NCT01115569?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 424 participants. The study started on 2010-05. Estimated completion is 2012-01.

What interventions are being tested in trial NCT01115569?

The interventions under investigation include: Hydrocodone Bitartrate (DRUG).

Who is sponsoring clinical trial NCT01115569?

This trial is sponsored by Zogenix, which has 9 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.