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

Postherpetic Neuralgia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106716
• Other study ID #: KAI-1678-003
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2010
• Last updated: August 30, 2011
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: August 2011
• Source: KAI Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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"

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• Placebo
Placebo IV Infusion
• KAI-1678
KAI-1678 IV Infusion
• Lidocaine
Lidocaine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KAI Pharmaceuticals	Trident Clinical Research Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	The effect of KAI-1678 on patient global response to treatment		Day 1	No
Secondary	The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS)		Day 1	No
Secondary	The number of adverse events as a measure of safety and tolerability of KAI-1678	Frequency of adverse events on each study treatment	Two weeks	Yes