Efficacy and Safety Study of SLC022 in Treating Pain Associated With Post Herpetic Neuralgia
NCT ID: NCT00813826
Last Updated: 2009-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
204 participants
INTERVENTIONAL
2009-01-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SLC022
300mg TID
SLC022
SLC022 150 mg capsule, 900mg daily dose
Placebo
Placebo capsule, TID
Placebo
Matching placebo capsule
Placebo
Placebo capsule, TID
Interventions
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SLC022
SLC022 150 mg capsule, 900mg daily dose
Placebo
Placebo capsule, TID
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Well established consistent pain during baseline phase.
4. Completed a washout period of 7 days for existing pain medications.
5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
6. A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
2. 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.
3. Previous neurolytic or neurosurgical therapy for PHN.
4. Treatment with local anesthetic nerve blocks within the last 30 days.
5. Failure of an adequate dose of 3 or more first line drug treatments for PHN-related pain due to efficacy.
6. Any other type of pain which may impair the self assessment of the pain due to PHN.
7. Skin conditions in the affected dermatome that could alter sensation.
8. Participation in other studies within 30 days before the current study begins and/or during study participation.
9. Taking CYP1A2 inhibitors such as fluvoxamine, certain fluoroquinolones (e.g., ciprofloxacin, enoxacin, pefloxacin, etc), mexiletine, and zileuton.
10. History of drug or alcohol abuse during the last 5 years.
11. Creatinine clearance \<50 mL/min.
12. History of malignancy other than basal cell carcinoma and carcinoma in situ.
13. History of chronic hepatitis B or C, or human immunodeficiency virus (HIV) infection.
14. Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease.
15. Immunocompromised state.
16. 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.
18 Years
ALL
No
Sponsors
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Solace Pharmaceuticals
INDUSTRY
Responsible Party
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Solace Pharmaceuticals Inc.
Principal Investigators
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Kevin Pojasek, PhD
Role: STUDY_DIRECTOR
Solace Pharmaceuticals Inc.
Locations
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Sierra Vista, Arizona, United States
Mission Viejo, California, United States
Orlando, Florida, United States
Plantation, Florida, United States
Marietta, Georgia, United States
Oak Brook, Illinois, United States
Shreveport, Louisiana, United States
Brockton, Massachusetts, United States
Omaha, Nebraska, United States
Rochester, New York, United States
Winston-Salem, North Carolina, United States
Kettering, Ohio, United States
Altoona, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
West Reading, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Midvale, Utah, United States
Countries
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Other Identifiers
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SLC022/201
Identifier Type: -
Identifier Source: org_study_id