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NCT04265456 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers
A Phase 1 study of Postoperative Pain, sponsored by Nevakar.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT04265456: Completed Phase 1 study of Postoperative Pain, sponsored by Nevakar.
NCT04265456 is a Phase 1 study of Postoperative Pain that has completed, run by Nevakar. The registered enrollment target is 63 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04265456, a Phase 1 study of Postoperative Pain, has completed, sponsored by Nevakar.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.
Primary Outcome
The incidence and severity of treatment-emergent adverse events
Conditions Studied
Interventions
- DRUG Pregabalin 100mg
- DRUG Acetaminophen 1300mg
Study Locations (1)
California
- Lotus Clinical Resarch,LLC - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2020-07-22 |
| Phase | Phase 1 |
What the finished NCT04265456 record still lists
NCT04265456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Pregabalin 100mg is the first listed.
NCT04265456 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04265456 about?
NCT04265456 is a clinical study titled "A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers". This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.
What is the current status of trial NCT04265456?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2020-01-14. Estimated completion is 2020-07-22.
What conditions does trial NCT04265456 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT04265456?
The interventions under investigation include: Pregabalin 100mg (DRUG), Acetaminophen 1300mg (DRUG).
Who is sponsoring clinical trial NCT04265456?
This trial is sponsored by Nevakar, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04265456 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04265456's enrollment target sits among peer trials
63 95th of 120 higher than 26 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain 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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