Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 is a Phase 1 study of Postoperative Pain that has completed, run by Nevakar. The registered enrollment target is 63 participants, below the 230-participant average among 63 other Postoperative Pain trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Interventions

  • DRUG Pregabalin 100mg
  • DRUG Acetaminophen 1300mg

Study Locations (1)

California

  • Lotus Clinical Resarch,LLC - Pasadena

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2020-01-14
Est. Completion 2020-07-22
Phase Phase 1

Sponsor

Nevakar

4 total trials

What the Registry Record Tells You About NCT04265456

The ClinicalTrials.gov registry entry for NCT04265456 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 230-participant average among 63 other Postoperative Pain trials with a reported enrollment target (73% lower). The listed sponsor is Nevakar, which has 4 total studies on file at ClinicalTrials.gov.

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

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.

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.