Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia

NCT ID: NCT01106716

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain

Detailed Description

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Conditions

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1: Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo IV Infusion

A2: KAI-1678

Experimental

Group Type EXPERIMENTAL

KAI-1678

Intervention Type DRUG

KAI-1678 IV Infusion

A3: Lidocaine

Lidocaine

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Lidocaine

Interventions

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Placebo

Placebo IV Infusion

Intervention Type DRUG

KAI-1678

KAI-1678 IV Infusion

Intervention Type DRUG

Lidocaine

Lidocaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
* pain score at least 4 on 11-point numerical rating scale (0-10)
* stable doses of analgesic medications for at least 1 month"

Exclusion Criteria

* diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
* pain score at least 4 on 11-point numerical rating scale (0-10)
* stable doses of analgesic medications for at least 1 month"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trident Clinical Research Pty Ltd

INDUSTRY

Sponsor Role collaborator

KAI Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Bell, MD

Role: STUDY_DIRECTOR

KAI Pharmaceuticals, Inc

Locations

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Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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KAI-1678-003

Identifier Type: -

Identifier Source: org_study_id

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