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NCT01886313 · ClinicalTrials.gov registry record · Phase 2

Civamide Nasal Solution for Postherpetic Neuralgia of the Trigeminal Nerve

A Phase 2 study, sponsored by Winston Laboratories.

Terminated
Registry status
Phase 2
Development phase
11
Enrollment target

NCT01886313 is a Phase 2 study that was terminated before completion, run by Winston Laboratories. The registered enrollment target is 11 participants.

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The verdict

NCT01886313, a Phase 2 study, was terminated before completion, sponsored by Winston Laboratories.

TERMINATED
Registry status
Phase 2
Development phase
11 participants
Enrollment target

Study Summary

Herpes zoster (commonly referred to as "shingles") results from the reactivation of the varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus lays dormant in the cells of the nerves until activated. Once activated, patients develop a characteristic red blistering rash which crusts and heals in 2 - 4 weeks. Postherpetic neuralgia (PHN), the term for pain persisting after the herpes zoster (HZ) eruption heals, is the most common and most feared complication of herpes zoster infection. The drug, Civamide is thought to desensitize the nerves and decrease the pain of PHN. This is the pharmacologic rationale for its use in the nose in postherpetic neuralgia of the trigeminal nerve, a nerve that is in the nose and transmits pain from the face. The objective of this study is to evaluate the safety and efficacy of intranasally administered Civamide (0.01%) for the treatment of moderate to severe daily pain associated with postherpetic neuralgia of the trigeminal nerve. Neuropathic pain must have persisted for ≥ 12 months.

Interventions

  • DRUG Placebo
  • DRUG Civamide Nasal Spray

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2014-03
Est. Completion 2015-04
Phase Phase 2

Sponsor

Winston Laboratories

8 total trials

What the Registry Record Tells You About NCT01886313

The ClinicalTrials.gov registry entry for NCT01886313 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Winston Laboratories, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01886313 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01886313 about?

NCT01886313 is a clinical study titled "Civamide Nasal Solution for Postherpetic Neuralgia of the Trigeminal Nerve". Herpes zoster (commonly referred to as "shingles") results from the reactivation of the varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus lays dormant in the cells of the nerves until activated. Once activated, patients develop a characteristic red blistering ...

What is the current status of trial NCT01886313?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2014-03. Estimated completion is 2015-04.

What interventions are being tested in trial NCT01886313?

The interventions under investigation include: Placebo (DRUG), Civamide Nasal Spray (DRUG).

Who is sponsoring clinical trial NCT01886313?

This trial is sponsored by Winston Laboratories, which has 8 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.