Postherpetic NeuralgiaPhase 2NCT00813826
Efficacy and Safety Study of SLC022 in Treating Pain Associated With Post Herpetic Neuralgia
A Phase 2 study testing SLC022 in people with Postherpetic Neuralgia, run by Solace Pharmaceuticals at 19 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain associated with post-herpetic neuralgia (PHN) in recently diagnosed patients. 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?
- SLC022
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 19 sitesUnited States
- Study dates
- Jan 2009to Nov 2009
- 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
- Male or female age 18 years or older.
- A history of cutaneous herpes zoster infection and sustained pain associated with the site of the herpes zoster skin rash for >6 months, after onset of the herpes zoster skin rash.
- Well established consistent pain during baseline phase.
- Completed a washout period of 7 days for existing pain medications.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Pregnant or breast feeding.
- Female subjects who are not surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least one year, or are not willing to practice adequate methods of contraception if of childbearing potential.
- Previous neurolytic or neurosurgical therapy for PHN.
- Treatment with local anesthetic nerve blocks within the last 30 days.
- Failure of an adequate dose of 3 or more first line drug treatments for PHN-related pain due to efficacy.
- Any other type of pain which may impair the self assessment of the pain due to PHN.
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- Skin conditions in the affected dermatome that could alter sensation.
- Participation in other studies within 30 days before the current study begins and/or during study participation.
- Taking CYP1A2 inhibitors such as fluvoxamine, certain fluoroquinolones (e.g., ciprofloxacin, enoxacin, pefloxacin, etc), mexiletine, and zileuton.
- History of drug or alcohol abuse during the last 5 years.
- Creatinine clearance <50 mL/min.
- History of malignancy other than basal cell carcinoma and carcinoma in situ.
- History of chronic hepatitis B or C, or human immunodeficiency virus (HIV) infection.
- Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease.
- Immunocompromised state.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Altoona, Pennsylvania, 16602
Study site
Brockton, Massachusetts, 20301
Study site
Dallas, Texas, 75230
Study site
Houston, Texas, 77074
Study site
Kettering, Ohio, 45429
Study site
Marietta, Georgia, 30060
Study site
Midvale, Utah, 84047
Study site
Mission Viejo, California, 92691
Study site
Oak Brook, Illinois, 60523
Study site
Omaha, Nebraska, 68134
Study site
Orlando, Florida, 32806
Study site
Philadelphia, Pennsylvania, 19139
Study site
Plantation, Florida, 33324
Study site
Rochester, New York, 14618
Study site
San Antonio, Texas, 78229
Study site
Shreveport, Louisiana, 71030
Study site
Sierra Vista, Arizona, 85635
Study site
West Reading, Pennsylvania, 19611
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Tolerability of Oral SLC022 300 mg TID, a Glial Cell Modulating Agent, Versus Placebo in the Treatment of Post Herpetic Neuralgia
The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain associated with post-herpetic neuralgia (PHN) in recently diagnosed patients.
Read the detailed description
This study will enroll subjects with established PHN, a stable pain intensity and that meet all other eligibility criteria.
- Conditions
- Postherpetic Neuralgia
- Being tested
- SLC022, Placebo
- Keywords
- PHN, Pain after Shingles
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLC022Drug
SLC022 150 mg capsule, 900mg daily dose
PlaceboDrug
Placebo capsule, TID
| Study group | Role | What they receive |
|---|---|---|
| SLC022 | Experimental | 300mg TID Receives: Drug: SLC022; Drug: Placebo |
| Placebo | Placebo comparator | Matching placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is the change in a subject's mean pain score from the baseline period to the end of the treatment period as measured using the 11-point Numerical Rating Scale.
Measured: 7 weeks
Secondary outcomes (1)
Determining the safety and tolerability of SLC022 300 mg TID compared to placebo TID in subjects with PHN by measuring changes in vital signs, ECG, hematology and other laboratory values, and subject-reported adverse events.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2009 (estimated)
- Study completionNov 2009 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solace Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kevin Pojasek, PhD, Study director, Solace Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813826
- Sponsor's protocol ID
- SLC022/201
- Status last verified
- Jul 2009
- First submitted
- 19 Dec 2008
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Tolerability of Oral SLC022 300 mg TID, a Glial Cell Modulating Agent, Versus Placebo in the Treatment of Post Herpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00813826
- Acronym / sponsor ID
- SLC022/201
- Conditions
- Postherpetic Neuralgia
- Keywords
- PHN, Pain after Shingles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Solace PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 23 Dec 2008 (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.
The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain associated with post-herpetic neuralgia (PHN) in recently diagnosed patients.
Detailed description
This study will enroll subjects with established PHN, a stable pain intensity and that meet all other eligibility criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLC022 | Experimental | Drug: SLC022, Drug: Placebo300mg TID |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female age 18 years or older.
- A history of cutaneous herpes zoster infection and sustained pain associated with the site of the herpes zoster skin rash for >6 months, after onset of the herpes zoster skin rash.
- Well established consistent pain during baseline phase.
- Completed a washout period of 7 days for existing pain medications.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Key exclusion criteria (16 listed)
- Pregnant or breast feeding.
- Female subjects who are not surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least one year, or are not willing to practice adequate methods of contraception if of childbearing potential.
- Previous neurolytic or neurosurgical therapy for PHN.
- Treatment with local anesthetic nerve blocks within the last 30 days.
- Failure of an adequate dose of 3 or more first line drug treatments for PHN-related pain due to efficacy.
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 |
|---|---|---|
| SLC022SLC022 150 mg capsule, 900mg daily dose | Drug | SLC022 |
| PlaceboPlacebo capsule, TID | Drug | Placebo, SLC022 |
Primary outcome
The primary endpoint of this study is the change in a subject's mean pain score from the baseline period to the end of the treatment period as measured using the 11-point Numerical Rating Scale.
Time frame: 7 weeks
1 secondary outcome
Determining the safety and tolerability of SLC022 300 mg TID compared to placebo TID in subjects with PHN by measuring changes in vital signs, ECG, hematology and other laboratory values, and subject-reported adverse events.
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2009.
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Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
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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.
Kevin Pojasek, PhD study director
Solace Pharmaceuticals Inc.
19 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 SLC022 in people with Postherpetic Neuralgia, run by Solace Pharmaceuticals at 19 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 16 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: status not confirmed, as of the sponsor's last update on 30 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
Results are not available in the source record.
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?
The primary endpoint of this study is the change in a subject's mean pain score from the baseline period to the end of the treatment period as measured using the 11-point Numerical Rating Scale. (time frame: 7 weeks). 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 30 Jul 2009.