Clinical trial NCT00813826: Efficacy and Safety Study of SLC022 in Treating Pain Associated With Post Herpetic Neuralgia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: PHN
Pain after Shingles
Lead sponsor: Solace Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study will enroll subjects with established PHN, a stable pain intensity and that meet all other eligibility criteria.

Eligibility criteria: Inclusion Criteria:

1. Male or female age 18 years or older.
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:

1. Pregnant or breast feeding.
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.

Primary outcomes:
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.
timeFrame: 7 weeks
Secondary outcomes:
measure: 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.
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Sierra Vista
country: United States
state: Arizona
city: Mission Viejo
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Oak Brook
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Brockton
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: Rochester
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Kettering
country: United States
state: Ohio
city: Altoona
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Midvale
country: United States
state: Utah
Study officials:
affiliation: Solace Pharmaceuticals Inc.
name: Kevin Pojasek, PhD
role: STUDY_DIRECTOR
References: