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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: Clinical Trial Phase 2 study, sponsored by Winston Laboratories.
NCT01886313 is a Phase 2 study that was terminated before completion, run by Winston Laboratories. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The change in the Average Daily Pain Score (11-point Numeric Rating Scale (NRS)) from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period. The minimum score is 0 and the maximum score is 10. A score of 0 indicates no pain while a score of 10 indicates worst possible pain.
Interventions
- DRUG Placebo
- DRUG Civamide Nasal Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
Why NCT01886313 stopped before completion
NCT01886313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01886313 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01886313's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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