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NCT02313103 · ClinicalTrials.gov registry record · Phase 1

Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects

A Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT02313103 is a Phase 1 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 16 participants.

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The verdict

NCT02313103, a Phase 1 study, has completed, sponsored by USWM, LLC (dba US WorldMeds).

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1 matches to each ESRD subjects, matched for gender, age, and BMI.

Interventions

  • DRUG lofexidine HCl

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2014-11
Est. Completion 2015-02
Phase Phase 1

Sponsor

USWM, LLC (dba US WorldMeds)

16 total trials

What the Registry Record Tells You About NCT02313103

The ClinicalTrials.gov registry entry for NCT02313103 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is USWM, LLC (dba US WorldMeds), which has 16 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which lofexidine HCl is the first listed.

NCT02313103 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02313103 about?

NCT02313103 is a clinical study titled "Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects". This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1 matches to each ESRD subjects, matched for gender, age, and BMI.

What is the current status of trial NCT02313103?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-11. Estimated completion is 2015-02.

What interventions are being tested in trial NCT02313103?

The interventions under investigation include: lofexidine HCl (DRUG).

Who is sponsoring clinical trial NCT02313103?

This trial is sponsored by USWM, LLC (dba US WorldMeds), which has 16 total clinical trials registered on ClinicalTrials.gov.

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.