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NCT04570436 · ClinicalTrials.gov registry record · Phase 4
Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience
A Phase 4 study, sponsored by Viatris Specialty.
- Completed
- Registry status
- Phase 4
- Development phase
- 52
- Enrollment target
NCT04570436: Completed Phase 4 study, sponsored by Viatris Specialty.
NCT04570436 is a Phase 4 study that has completed, run by Viatris Specialty. The registered enrollment target is 52 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04570436, a Phase 4 study, has completed, sponsored by Viatris Specialty.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 52 participants
- Enrollment target
Study Summary
This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5 treatment, 10 sequence, 5 period crossover single dose, Williams square design study in healthy adult, non drug dependent male and female participants with drug abuse experience with sedative drugs.
Primary Outcome
Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"
Interventions
- OTHER placebo
- DRUG gabapentin 600 mg
- DRUG gabapentin 1200 mg
- DRUG gabapentin 1800 mg
- DRUG diazepam 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2022-11-10 |
| Phase | Phase 4 |
What the finished NCT04570436 record still lists
NCT04570436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT04570436 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04570436 about?
NCT04570436 is a clinical study titled "Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience". This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5 treatment, 10 sequence, 5 period crossover single dose, Williams square design study in healthy adult, non drug dependent male and female participants with drug abuse experience with sedative drugs.
What is the current status of trial NCT04570436?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2021-03-29. Estimated completion is 2022-11-10.
What interventions are being tested in trial NCT04570436?
The interventions under investigation include: placebo (OTHER), gabapentin 600 mg (DRUG), gabapentin 1200 mg (DRUG), gabapentin 1800 mg (DRUG), diazepam 20 mg (DRUG).
Who is sponsoring clinical trial NCT04570436?
This trial is sponsored by Viatris Specialty, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04570436's enrollment target sits among peer trials
52 1233rd of 2000 higher than 752 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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