Efficacy and Safety Study of SLC022 in Treating Pain Associated With Post Herpetic Neuralgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Solace Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Solace Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00813826
First received: December 19, 2008
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Postherpetic Neuralgia
Drug: SLC022
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Solace Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 204
Study Start Date: January 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SLC022
300mg TID
Drug: SLC022
SLC022 150 mg capsule, 900mg daily dose
Drug: Placebo
Placebo capsule, TID
Placebo Comparator: Placebo
Matching placebo capsule
Drug: Placebo
Placebo capsule, TID

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813826

Locations
United States, Arizona
Sierra Vista, Arizona, United States, 85635
United States, California
Mission Viejo, California, United States, 92691
United States, Florida
Orlando, Florida, United States, 32806
Plantation, Florida, United States, 33324
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Illinois
Oak Brook, Illinois, United States, 60523
United States, Louisiana
Shreveport, Louisiana, United States, 71030
United States, Massachusetts
Brockton, Massachusetts, United States, 20301
United States, Nebraska
Omaha, Nebraska, United States, 68134
United States, New York
Rochester, New York, United States, 14618
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Kettering, Ohio, United States, 45429
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16602
Philadelphia, Pennsylvania, United States, 19139
West Reading, Pennsylvania, United States, 19611
United States, Texas
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77074
San Antonio, Texas, United States, 78229
United States, Utah
Midvale, Utah, United States, 84047
Sponsors and Collaborators
Solace Pharmaceuticals
Investigators
Study Director: Kevin Pojasek, PhD Solace Pharmaceuticals Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Kevin Pojasek, Senior Director, Development Programs Leader, Solace Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00813826     History of Changes
Other Study ID Numbers: SLC022/201
Study First Received: December 19, 2008
Last Updated: July 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Solace Pharmaceuticals:
PHN
Pain after Shingles

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014