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

This study has been completed.
Sponsor:
Collaborator:
Trident Clinical Research Pty Ltd
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01106716
First received: April 16, 2010
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Postherpetic Neuralgia
 Drug: Placebo
Drug: KAI-1678
Drug: Lidocaine
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6). [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The effect of KAI-1678 on patient global response to treatment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • The number of adverse events as a measure of safety and tolerability of KAI-1678 [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
    Frequency of adverse events on each study treatment


Enrollment: 23
Study Start Date: March 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A1: Placebo
Placebo
 Drug: Placebo
Placebo IV Infusion
Experimental: A2: KAI-1678
Experimental
 Drug: KAI-1678
KAI-1678 IV Infusion
Active Comparator: A3: Lidocaine
Lidocaine
 Drug: Lidocaine
Lidocaine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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"
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106716

Locations
Australia, New South Wales
Sydney, New South Wales, Australia
Sponsors and Collaborators
KAI Pharmaceuticals
Trident Clinical Research Pty Ltd
Investigators
Study Director: Gregory Bell, MD KAI Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01106716     History of Changes
Other Study ID Numbers: KAI-1678-003
Study First Received: April 16, 2010
Last Updated: August 30, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by KAI Pharmaceuticals:
Lidocaine
Lignocaine
Analgesics. Non-narcotic / therapeutic use
Neuralgia, Postherpetic
 Pain
Pain measurement / drug effect
Pain postoperative / drug therapy
PHN

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013