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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: Completed Phase 4 study of Opioid Dependence, sponsored by Indivior.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer?
Conditions Studied
Interventions
- DRUG Suboxone Sublingual Film
- DRUG Zubsolv sublingual tablets
Study Locations (1)
Florida
- Hill Top Research - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-11 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
What the finished NCT02038790 record still lists
NCT02038790 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 157-participant average among 29 other Opioid Dependence trials with a reported enrollment target (79% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02038790's enrollment target sits among peer trials
33 22nd of 29 higher than 8 of 29 other Opioid Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Dependence 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.
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