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NCT00758433 · ClinicalTrials.gov registry record · Phase 1

Civamide Patch Safety, Tolerability and PK Study

A Phase 1 study of Healthy Volunteers, sponsored by Winston Laboratories.

Completed
Registry status
Phase 1
Development phase
39
Enrollment target
1
Study location

NCT00758433 is a Phase 1 study of Healthy Volunteers that has completed, run by Winston Laboratories. The registered enrollment target is 39 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00758433, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Winston Laboratories.

COMPLETED
Registry status
Phase 1
Development phase
39 participants
Enrollment target
1
Study location

Study Summary

To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and 0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug from civamide patch in a subset of study subjects.

Conditions Studied

Healthy Volunteers

Interventions

  • DRUG Placebo patch
  • DRUG Zucapsaicin

Study Locations (1)

New York

  • International Research Services, Inc. - Port Chester

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2008-09
Est. Completion 2009-04
Phase Phase 1

Sponsor

Winston Laboratories

8 total trials

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What the Registry Record Tells You About NCT00758433

The ClinicalTrials.gov registry entry for NCT00758433 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (92% lower). The listed sponsor is Winston Laboratories, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo patch is the first listed.

NCT00758433 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00758433 about?

NCT00758433 is a clinical study titled "Civamide Patch Safety, Tolerability and PK Study". To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and 0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug from civamide patch in a...

What is the current status of trial NCT00758433?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2008-09. Estimated completion is 2009-04.

What conditions does trial NCT00758433 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT00758433?

The interventions under investigation include: Placebo patch (DRUG), Zucapsaicin (DRUG).

Who is sponsoring clinical trial NCT00758433?

This trial is sponsored by Winston Laboratories, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00758433 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.