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NCT02038790 · ClinicalTrials.gov registry record · Phase 4

Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population

A Phase 4 study of Opioid Dependence, sponsored by Indivior.

Completed
Registry status
Phase 4
Development phase
33
Enrollment target
1
Study location

NCT02038790 is a Phase 4 study of Opioid Dependence that has completed, run by Indivior. The registered enrollment target is 33 participants, below the 157-participant average among 29 other Opioid Dependence trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02038790, a Phase 4 study of Opioid Dependence, has completed, sponsored by Indivior.

COMPLETED
Registry status
Phase 4
Development phase
33 participants
Enrollment target
1
Study location

Study Summary

The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7 mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate drugs like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of time.

Conditions Studied

Opioid Dependence

Interventions

  • DRUG Suboxone Sublingual Film
  • DRUG Zubsolv sublingual tablets

Study Locations (1)

Florida

  • Hill Top Research - St. Petersburg

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2013-11
Est. Completion 2013-11
Phase Phase 4

Sponsor

Indivior

37 total trials

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What the Registry Record Tells You About NCT02038790

The ClinicalTrials.gov registry entry for NCT02038790 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 157-participant average among 29 other Opioid Dependence trials with a reported enrollment target (79% lower). The listed sponsor is Indivior, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid Dependence appearing as the primary indexed condition, and to 2 interventions - of which Suboxone Sublingual Film is the first listed.

NCT02038790 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT02038790 about?

NCT02038790 is a clinical study titled "Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population". The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7 mg buprenorphine and 1.4 mg n...

What is the current status of trial NCT02038790?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2013-11. Estimated completion is 2013-11.

What conditions does trial NCT02038790 study?

This clinical trial studies the following conditions: Opioid Dependence.

What interventions are being tested in trial NCT02038790?

The interventions under investigation include: Suboxone Sublingual Film (DRUG), Zubsolv sublingual tablets (DRUG).

Who is sponsoring clinical trial NCT02038790?

This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02038790 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.