Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia
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
1 other identifier
interventional
23
1 country
1
Brief Summary
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 16, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedSeptember 2, 2025
August 1, 2025
1 year
April 16, 2010
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 1
Secondary Outcomes (4)
The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours
Day 1
The effect of KAI-1678 on patient global response to treatment
Day 1
The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS)
Day 1
The number of adverse events as a measure of safety and tolerability of KAI-1678
Two weeks
Study Arms (3)
A1: Placebo
PLACEBO COMPARATORPlacebo
A2: KAI-1678
EXPERIMENTALExperimental
A3: Lidocaine
ACTIVE COMPARATORLidocaine
Interventions
Eligibility Criteria
You may qualify if:
- 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"
You may not qualify if:
- 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"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KAI Pharmaceuticalslead
- Trident Clinical Research Pty Ltdcollaborator
Study Sites (1)
Unknown Facility
Sydney, New South Wales, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gregory Bell, MD
KAI Pharmaceuticals, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2010
First Posted
April 20, 2010
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
September 2, 2025
Record last verified: 2025-08