- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02644421
Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica) (LMR)
March 16, 2018 updated by: Christine N. Sang, MD, MPH, Brigham and Women's Hospital
Phase Ib Randomized, Double-Blind, Latin Square Crossover, Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 v. Lidocaine v. Placebo in Lumbar Radiculopathy
Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single intravenous dose administration of VVZ-149.
To demonstrate assay sensitivity, lidocaine will be administered as a positive control.
The study will take place during a single inpatient visit involving three separate treatment periods, each with a washout of (>16-hours.
Study drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
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
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Translational Pain Research, Brigham and Women's Hospital
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-
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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must have a history of persistent pain secondary to unilateral monoradiculopathy present for a minimum of 3 months prior to the study, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
- Males or females between 18 and 70 years of age, inclusive. Females who are pregnant or breastfeeding will be excluded from the trial.
- Subjects must be in generally good health, either using no medication or using a stabilized medication regimen for chronic and well-controlled conditions such as hypertension, allergies, stable endocrinopathies (e.g. hypothyroidism), etc. Subjects with other active diseases will be reviewed on a case-by-case basis by the principal investigator.
- No concomitant therapy with any medication that is a known significant inhibitor or inducer of CYP450 2D6 and CYP3A4, at the discretion of the PI.
Normal or clinically insignificant screening laboratory tests:
- Serum BUN, creatinine, bicarbonate, calcium, chloride, potassium, sodium, lactate dehydrogenase, inorganic phosphate, total protein, glucose, albumin, and uric acid. WBC, absolute neutrophil count, hemoglobin, hematocrit, and platelets. SGOT (AST), SGPT (ALT), total bilirubin, alkaline phosphatase, TSH/T4, urinalysis, and urine toxicology screen.
- Electrocardiogram (12-lead). Any significant laboratory abnormalities will be reviewed by the principal investigator prior to inclusion of the subject in the study.
- Willingness to restrict analgesic therapy during inpatient admission days to the allowed rescue analgesic agent permitted by the study (acetaminophen).
- Subjects must have normal cognitive function and communicative ability in the English language.
- Subjects must be able to provide meaningful written informed consent.
- Subjects must be able to maintain complete required questionnaires, and must be able to fulfill all other conditions of the protocol.
Exclusion Criteria:
- Female subjects who are pregnant or breastfeeding, or plan to become pregnant while participating in the study.
- Subjects with a previous history of multiple or severe drug allergies, including lidocaine.
- Subjects with a history of or current chronic substance abuse, including alcohol.
- Subjects who have participated in a study of an investigational drug or device within 30 days prior to screening for this study. Subjects must agree not to participate in other investigational drug or device studies during the entire course of this study (beginning with the screening visit).
Subjects with the following abnormal clinical evaluations:
- Impaired renal function defined as BUN > 45 or creatinine >2.0 and/or impaired liver function defined as liver transaminases, alkaline phosphatase, or bilirubin greater than 1.5 x upper limit of normal laboratory values.
- Prolonged PR (>200 ms) interval on electrocardiogram (12-lead). Subjects presenting with the above laboratory abnormalities may be allowed on a case-by-case basis at the discretion of the principal investigator.
- Subjects who intend to donate blood or blood products while participating in this study, and for 30 days following completion of the study.
- Subjects with clinically significant renal, hepatic, or cardiac disease, with seizure disorders, or with a clinical history of life-threatening arrhythmias (i.e. torsades de pointes).
- Subjects with a severe neuropsychiatric disorder requiring treatment.
- Subjects with sensitivity to amide-type local anesthetics.
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 Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VVZ-149
The following doses will be administered intravenously:
|
|
Active Comparator: Lidocaine
The following doses will be administered intravenously:
|
|
Placebo Comparator: Placebo
Normal saline administered intravenously over 8 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with treatment-related Adverse Events as assessed using an internal, categorical severity/relationship scale
Time Frame: over 8 hour infusion
|
The number of subjects who report mild, moderate or severe treatment-emergent adverse events that are deemed by the investigator to be possibly, probably, or definitely related to the study medication
|
over 8 hour infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Pain Intensity using the 11-pt Likert Pain Intensity Scale
Time Frame: over 8 hour infusion
|
Reductions in pain intensity from baseline will be calculated using data obtained over the 8 hour infusion from the 11-pt Likert Pain Intensity Scale
|
over 8 hour infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christine N Sang, MD MPH, Brigham and Women's Hospital
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
November 1, 2015
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
December 8, 2015
First Submitted That Met QC Criteria
December 30, 2015
First Posted (Estimate)
December 31, 2015
Study Record Updates
Last Update Posted (Actual)
March 19, 2018
Last Update Submitted That Met QC Criteria
March 16, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Sciatic Neuropathy
- Mononeuropathies
- Peripheral Nervous System Diseases
- Neuralgia
- Sciatica
- Radiculopathy
- 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
- 2015-P-002050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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