Status and phase
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About
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects with chronic pain conditions other than PHN as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
Subjects with a recent history of seizure within the past 5 years.
Subjects who use opioids more than 4 days per week.
Subjects with clinically unstable medical conditions, including cardiac disease (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia); respiratory disease; biliary tract disease; hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study.
Subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (PI) to be at serious risk of suicide.
PHN-pain-condition-specific exclusions:
Active-comparator-related exclusions:
Other protocol specific inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
105 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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