Postherpetic NeuralgiaPhase 2PHNNCT01757873
Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia
A Phase 2 study testing Z160 in people with Postherpetic Neuralgia, run by Zalicus at 53 sites in United States.
Trial summary
This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Z160
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 53 sitesUnited States
- Study dates
- Dec 2012to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- Either sex but must be aged >=18 years.
- Diagnosis of PHN as defined by the presence of pain in the area affected by herpes zoster >=6 months after the herpes zoster skin rash has healed.
- Pain score over the last week of >=3 and <=8 on the PI-NRS
- If female, the subject must be postmenopausal , surgically sterilized for >=3 months before the screening visit, or agree to use 2 reliable methods of contraception if of childbearing potential. If male, the subject must agree to use condoms.
- Willing and able to comply with all study procedures.
Who cannot join
- Severe pain caused by diseases other than PHN.
- Neurolytic or neurosurgical therapy for PHN within 6 months of screening (subjects who received a spinal cord stimulator implant at least 6 months before screening are eligible, but the settings need to remain stable during the double blind study period without use of a magnet).
- History of seizure, excluding pediatric febrile seizures, or currently has seizures.
- Stroke or transient ischemic attack (TIA) <=6 months before the screening visit.
- History of or a current diagnosis of schizophrenia or bipolar disorder.
- Major depressive disorder or generalized anxiety disorder <=6 months before the screening visit. Subjects who are on stable doses of selective serotonin uptake inhibitors (SSRIs) for depression (other than major depressive disorder) are eligible for the study.
Show all 18Show fewer
- Clinically significant alcohol or substance dependency <=1 year before the screening visit
- Imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within 6 months before the screening visit.
- Clinically significant conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety.
- Malignancy (other than nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of other organs that was surgically removed >1 year before screening and has not recurred).
- Condition that is known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Illness within 30 days before screening.
- History of hypersensitivity to calcium channel blockers.
- Multiple drug allergies
- Opioids (at doses exceeding the equivalent of 15 mg of oral morphine) or a high-dose capsaicin patch (Qutenza) <=30 days before the screening visit.
- Moderate or strong cytochrome P450 inducer within 30 days before the screening visit.
- Digoxin or prohibited medications that cannot be discontinued before randomization.
- Other exclusions apply.
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Investigative Site
Albuquerque, New Mexico, 87102
Investigative Site
Ann Arbor, Michigan, 48104
Investigative Site
Austin, Texas, 78731
Investigative Site
Bay City, Michigan, 48706
Investigative Site
Beavercreek, Ohio, 45432
Investigative Site
Bellevue, Washington, 98007
Investigative Site
Birmingham, Alabama, 35216
Investigative Site
Boston, Massachusetts, 02131
Investigative Site
Boulder, Colorado, 80304
Investigative Site
Brooklyn, New York, 11235
Investigative Site
Brooksville, Florida, 34601
Investigative Site
Chandler, Arizona, 85224
Investigative Site
Charleston, South Carolina, 29407
Investigative Site
Chicago, Illinois, 60602
Investigative Site
Clearwater, Florida, 33756
Investigative Site
Colorado Springs, Colorado, 80920
Investigative Site
Columbia, Maryland, 21045
Investigative Site
Columbus, Ohio, 43214
Investigative Site
Denver, Colorado, 80218
Investigative Site
Evansville, Indiana, 47714
Investigative Site
Greensboro, North Carolina, 27410
Investigative Site
Hazelwood, Missouri, 63031
Investigative Site
Herndon, Virginia, 20171
Investigative Site
Irvine, California, 92618
Investigative Site
Kansas City, Missouri, 64114
Investigative Site
Kettering, Ohio, 45429
Investigative Site
Little Rock, Arkansas, 72205
Investigative Site
Los Angeles, California, 90033
Investigative Site
Mesa, Arizona, 85213
Investigative Site
Miami, Florida, 33015
Investigative Site
Murray, Utah, 84123
Investigative Site
Nashville, Tennessee, 37205
Investigative Site
New York, New York, 10016
Investigative Site
Ocean Springs, Mississippi, 39564
Investigative Site
Oklahoma City, Oklahoma, 73112
Investigative Site
Omaha, Nebraska, 68124
Investigative Site
Orlando, Florida, 32806
Investigative Site
Peoria, Arizona, 85381
Investigative Site
Phoenix, Arizona, 85020
Investigative Site
Port Orange, Florida, 32127
Investigative Site
Richardson, Texas, 75080
Investigative Site
Royal Palm Beach, Florida, 33411
Investigative Site
Salt Lake City, Utah, 84106
Investigative Site
San Francisco, California, 94109
Investigative Site
Sarasota, Florida, 34243
Investigative Site
Scottsdale, Arizona, 85251
Investigative Site
Shreveport, Louisiana, 71105
Investigative Site
St Louis, Missouri, 63117
Investigative Site
Tacoma, Washington, 98405
Investigative Site
Tampa, Florida, 33606
Investigative Site
Thousand Oaks, California, 91360
Investigative Site
Toms River, New Jersey, 08755
Investigative Site
Tullahoma, Tennessee, 37388
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Z160 in Subjects With Postherpetic Neuralgia
This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks.
- Conditions
- Postherpetic Neuralgia
- Being tested
- Z160, Placebo
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z160Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Z160 | Experimental | 375 mg BID Receives: Drug: Z160 |
| Placebo | Placebo comparator | matching placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS)
Measured: Baseline to Week 6
Secondary outcomes (13)
Change from baseline in weekly average pain score
Measured: Baseline to Weeks 1, 2, 3, 4, 5, 6
Neuropathic Pain Scale (NPS)
Measured: Baseline to Weeks 1, 2, 4, 6
Patient Global Impression of Change (PGIC)
Measured: Baseline to Week 6
Profile of Mood States (POMS)
Measured: Baseline to Weeks 1, 2, 4, 6
Daily Sleep Interference Scale (DSIS)
Measured: Baseline to Weeks 1, 2, 3, 4, 5, 6
Short Form 36 (SF-36)
Measured: Baseline to Week 6
Z160 plasma concentrations
Measured: Baseline to Weeks 1, 2, 4, 6
Time to a >= 30% reduction in weekly average pain score
Measured: Baseline to Weeks 1, 2, 3, 4, 5, 6
Time to a >= 50% reduction in weekly average pain score
Measured: Baseline to Weeks 1, 2, 3, 4, 5, 6
Subjects who have >= 30% reduction in average daily pain score
Measured: Baseline to Week 6
Subjects who have >= 50% reduction in average daily pain score
Measured: Baseline to Week 6
Safety and tolerability
As measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events
Measured: Baseline to Weeks 1- 12
Amount of rescue medication used
Measured: Baseline to Weeks 1, 2, 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zalicus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757873
- Sponsor's protocol ID
- Z160-PHN-202
- Acronym
- PHN
- Status last verified
- Dec 2013
- First submitted
- 7 Dec 2012
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Z160 in Subjects With Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT01757873
- Acronym / sponsor ID
- PHN / Z160-PHN-202
- Conditions
- Postherpetic Neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- ZalicusIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z160 | Experimental | Drug: Z160375 mg BID |
| Placebo | Placebo comparator | Drug: Placebomatching placebo control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written informed consent.
- Either sex but must be aged >=18 years.
- Diagnosis of PHN as defined by the presence of pain in the area affected by herpes zoster >=6 months after the herpes zoster skin rash has healed.
- Pain score over the last week of >=3 and <=8 on the PI-NRS
- If female, the subject must be postmenopausal , surgically sterilized for >=3 months before the screening visit, or agree to use 2 reliable methods of contraception if of childbearing potential. If male, the subject must agree to use condoms.
Key exclusion criteria (18 listed)
- Severe pain caused by diseases other than PHN.
- Neurolytic or neurosurgical therapy for PHN within 6 months of screening (subjects who received a spinal cord stimulator implant at least 6 months before screening are eligible, but the settings need to remain stable during the double blind study period without use of a magnet).
- History of seizure, excluding pediatric febrile seizures, or currently has seizures.
- Stroke or transient ischemic attack (TIA) <=6 months before the screening visit.
- History of or a current diagnosis of schizophrenia or bipolar disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z160 | Drug | Z160 |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS)
Time frame: Baseline to Week 6
13 secondary outcomes
Change from baseline in weekly average pain score
Time frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
Neuropathic Pain Scale (NPS)
Time frame: Baseline to Weeks 1, 2, 4, 6
Patient Global Impression of Change (PGIC)
Time frame: Baseline to Week 6
Profile of Mood States (POMS)
Time frame: Baseline to Weeks 1, 2, 4, 6
Daily Sleep Interference Scale (DSIS)
Time frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
Short Form 36 (SF-36)
Time frame: Baseline to Week 6
Z160 plasma concentrations
Time frame: Baseline to Weeks 1, 2, 4, 6
Time to a >= 30% reduction in weekly average pain score
Time frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
Time to a >= 50% reduction in weekly average pain score
Time frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
Subjects who have >= 30% reduction in average daily pain score
Time frame: Baseline to Week 6
Subjects who have >= 50% reduction in average daily pain score
Time frame: Baseline to Week 6
Safety and tolerability
Time frame: Baseline to Weeks 1- 12
Amount of rescue medication used
Time frame: Baseline to Weeks 1, 2, 4 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Z160 in people with Postherpetic Neuralgia, run by Zalicus at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS) (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.