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NCT02487108 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy

A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 3
Development phase
569
Enrollment target

NCT02487108 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 569 participants.

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The verdict

NCT02487108, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 3
Development phase
569 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating participants with moderate to severe pain following bunionectomy.

Interventions

  • DRUG Placebo
  • DRUG TV-46763

Trial Details

FieldValue
Enrollment Target 569 participants
Start Date 2015-08-11
Est. Completion 2016-03-30
Phase Phase 3

What the Registry Record Tells You About NCT02487108

The ClinicalTrials.gov registry entry for NCT02487108 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 569 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02487108 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02487108 about?

NCT02487108 is a clinical study titled "Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy". The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating participants with moderate to sever...

What is the current status of trial NCT02487108?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 569 participants. The study started on 2015-08-11. Estimated completion is 2016-03-30.

What interventions are being tested in trial NCT02487108?

The interventions under investigation include: Placebo (DRUG), TV-46763 (DRUG).

Who is sponsoring clinical trial NCT02487108?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 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.