- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01106716
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia
August 30, 2011 updated by: KAI Pharmaceuticals
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
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: A1: Placebo
Placebo
|
Placebo IV Infusion
|
EXPERIMENTAL: A2: KAI-1678
Experimental
|
KAI-1678 IV Infusion
|
ACTIVE_COMPARATOR: A3: Lidocaine
Lidocaine
|
Lidocaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
|
The effect of KAI-1678 on patient global response to treatment
Time Frame: Day 1
|
Day 1
|
|
The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS)
Time Frame: Day 1
|
Day 1
|
|
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
|
Two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
April 1, 2010
Study Registration Dates
First Submitted
April 16, 2010
First Submitted That Met QC Criteria
April 19, 2010
First Posted (ESTIMATE)
April 20, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
September 1, 2011
Last Update Submitted That Met QC Criteria
August 30, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Neuralgia, Postherpetic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- KAI-1678-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postherpetic Neuralgia
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedPostherpetic Neuralgia ( PHN )China
-
Yonsei UniversityWithdrawnThe Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic NeuralgiaThoracic Postherpetic NeuralgiaKorea, Republic of
-
Shanghai SIMR Biotechnology Co., Ltd.CompletedPostherpetic NeuralgiaChina, Australia
-
Haisco Pharmaceutical Group Co., Ltd.CompletedPostherpetic NeuralgiaChina
-
Cairo UniversityCompleted
-
Korea University Guro HospitalUnknownNeuralgia,PostherpeticKorea, Republic of
-
Second Affiliated Hospital, School of Medicine,...CompletedPostherpetic NeuralgiaChina
-
Cubist Pharmaceuticals LLCPfizerTerminatedPostherpetic NeuralgiaUnited States
-
PfizerTerminatedPostherpetic NeuralgiaUnited States, Germany, Austria, South Africa
-
ZalicusCompletedPostherpetic NeuralgiaUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States