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

Phase 2CompletedNCT01106716

KAI Pharmaceuticals23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postherpetic Neuralgia

Interventions

PlaceboDRUG

Placebo IV Infusion

KAI-1678DRUG

KAI-1678 IV Infusion

LidocaineDRUG

Lidocaine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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"

Locations (1)

Unnamed facility

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).

Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours.

Time frame: Day 1

Secondary Outcomes

The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours

Time frame: Day 1

The effect of KAI-1678 on patient global response to treatment

Time frame: Day 1

The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS)

Time frame: Day 1

The number of adverse events as a measure of safety and tolerability of KAI-1678

Frequency of adverse events on each study treatment

Time frame: Two weeks

Data from ClinicalTrials.gov

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