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Completed

NCT Number: NCT01106716

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

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

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Key information

Conditions

Postherpetic Neuralgia Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Placebo

Drug

Placebo IV Infusion

KAI-1678

Drug

KAI-1678 IV Infusion

Lidocaine

Drug

Lidocaine

Primary outcomes

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

    Time frame: Day 1

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

Secondary outcomes

  1. 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

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

    Time frame: Day 1

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

    Time frame: Day 1

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

    Time frame: Two weeks

    Frequency of adverse events on each study treatment

Sponsors and collaborators

Lead sponsor

KAI Pharmaceuticals

Industry

Collaborators

  • Trident Clinical Research Pty Ltd

Registry information

Official study title

A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Postherpetic Neuralgia

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 20, 2010
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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