- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01886313
Civamide Nasal Solution for Postherpetic Neuralgia of the Trigeminal Nerve
January 10, 2017 updated by: Winston Laboratories
A DOUBLE BLIND, RANDOMIZED, VEHICLE-CONTROLLED, PARALLEL-GROUP EVALUATION OF CIVAMIDE (ZUCAPSAICIN) 0.01% AND VEHICLE NASAL SPRAYS IN THE TREATMENT OF POSTHERPETIC NEURALGIA OF THE TRIGEMINAL NERVE
Herpes zoster (commonly referred to as "shingles") results from the reactivation of the varicella-zoster virus acquired during a primary infection, usually chickenpox.
The virus lays dormant in the cells of the nerves until activated.
Once activated, patients develop a characteristic red blistering rash which crusts and heals in 2 - 4 weeks.
Postherpetic neuralgia (PHN), the term for pain persisting after the herpes zoster (HZ) eruption heals, is the most common and most feared complication of herpes zoster infection.
The drug, Civamide is thought to desensitize the nerves and decrease the pain of PHN.
This is the pharmacologic rationale for its use in the nose in postherpetic neuralgia of the trigeminal nerve, a nerve that is in the nose and transmits pain from the face.
The objective of this study is to evaluate the safety and efficacy of intranasally administered Civamide (0.01%) for the treatment of moderate to severe daily pain associated with postherpetic neuralgia of the trigeminal nerve.
Neuropathic pain must have persisted for ≥ 12 months.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
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
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California
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Santa Monica, California, United States, 90404
- California Medical Clinic for Headache
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Florida
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Lauderdale Lakes, Florida, United States, 33319
- Sun Rise Medical
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Tampa, Florida, United States, 33606
- Meridien Research
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Michigan
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Ann Arbor, Michigan, United States, 48104
- Michigan Head Pain and Neurological Institute
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Texas
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Austin, Texas, United States, 78731
- Furture Search Trials of Neurology, LP
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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
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
- Subject is in generally good health other than a history of postherpetic neuralgia, determined by pre-study medical evaluation (medical history, physical examination including examination of the treatment area, and vital signs) and without evidence of underlying unstable acute or chronic systemic disease, e.g. diabetes.
- Subject has experienced on average, moderate to severe chronic postherpetic neuralgia restricted to the distribution of the affected trigeminal nerve or its divisions for at least 12 months after healing of a herpes zoster skin rash.
- Subject has Average Daily Pain Score of 4 or higher on the 11-point numeric rating scale during the 7-Day Baseline Period.
- Males or females between 21 to 80 years of age, inclusive.
- Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout the study or females of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year). A negative urine pregnancy test must be confirmed at screening for all female subjects who are not surgically sterile.
- The subject agrees not to begin any new concomitant medications during their participation in study.
Exclusion Criteria:
- Subject has a history of frequent headache or other painful conditions, other than that associated with PHN, within the past 30 days that has required or is expected to require the additional use (beyond stable daily doses) of prescription or over the counter pain relief medication, such as non-steroidal anti-inflammatory agents, including COX-2 inhibitors, systemic opiates or derivatives, or acetaminophen more than 2 times per week during the study. Concurrent medications and stable dose requirements are listed in Table 3.
- Clinical, historical or previous laboratory evidence of significant cardiovascular, renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological, psychological, or other systemic disease that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk to the subject.
- Presence of a significant nasal disorder.
- Subject is immunocompromised (e.g. AIDS, significant oncologic disease, immunocompromising medications, etc.).
- Subject received neurolytic or neurosurgical therapy for this or previous episodes of postherpetic neuralgia.
- Use of any restricted medication within the given time period prior to the Baseline Period and throughout the study (see Table 1).
- Subject has a history of alcohol and/or drug abuse within the past year.
- Subject has previously participated in a Civamide study.
- Subject has participated in another investigational study or taken another investigational drug within the past 30 days.
- Subject has difficulty distinguishing his/her PHN head pain from other types of head pain, such as tension-type headaches.
- Known hypersensitivity to or contraindication to the use of Civamide (zucapsaicin), capsaicin (Zuacta®, Zostrix®, Zostrix-HP®, Axsain®, or related products) or to any excipient of the clinical formulation.
- Initiation of a medication, discontinuation of a medication or change in regimen of existing medication(s) or therapies less than the required period of stable dosing prior to entering the Baseline Period. (See table 2.)
- If, for any other reason, the subject is not deemed to be suitable by the Investigator, they should not be enrolled.
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: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Civamide Nasal Spray
Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
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Placebo Comparator: Placebo Nasal Spray
Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Daily Pain Score
Time Frame: 6 weeks
|
The change in the Average Daily Pain Score (11-point Numeric Rating Scale (NRS)) from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period.
The minimum score is 0 and the maximum score is 10.
A score of 0 indicates no pain while a score of 10 indicates worst possible pain.
|
6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
June 20, 2013
First Submitted That Met QC Criteria
June 24, 2013
First Posted (Estimate)
June 25, 2013
Study Record Updates
Last Update Posted (Actual)
March 1, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WL-1001-07-01
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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