Neuralgia, Postherpetic Clinical Trial
Official title:
A Phase 2, Double Blind, Placebo Controlled, Dose-Ranging Study in Subjects With Postherpetic Neuralgia (PHN) to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Four Doses of TAK-583, Compared With Placebo
The purpose of this study is to evaluate the efficacy of TAK-583, once daily (QD), in relieving pain in subjects with postherpetic neuralgia.
Postherpetic neuralgia is defined as neuropathic pain still present 3 months following
healing of the herpes zoster rash. Symptoms of postherpetic neuralgia may include a complex
combination of symptoms, including a deep aching, shooting or burning pain, sensory
deficits, hyperalgesia, allodynia, paresthesia, and dysesthesia. Postherpetic neuralgia is
more common in the elderly, and it can have a debilitating effect on a patient. The most
commonly prescribed treatments are tricyclic antidepressants and anticonvulsants, however
these treatments are effective in approximately half of subjects and may also have
undesirable side effects (eg, dizziness and somnolence).
TAK-583 is a synthetic compound under development by Takeda Global Research & Development
Center, Inc. as a treatment for neuropathic pain and for delaying the progression of
diabetic neuropathy.
Individuals who want to participate in this study will be required to provide written
informed consent. Study participation is anticipated to be about 11 Weeks. Multiple
procedures will occur at each visit which may include fasting, blood collection, urine
collection, vital signs, body height and weight, physical examinations and
electrocardiograms.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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