NCT00377598

Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic Neuralgia

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of TAK-583, once daily (QD), in relieving pain in subjects with postherpetic neuralgia.

Detailed description

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.

Conditions

• Neuralgia, Postherpetic

Interventions

Type	Name	Description
DRUG	TAK-583	TAK-583 5 mg, tablets, orally, once daily for up to 8 weeks
DRUG	TAK-583	TAK-583 25 mg, tablets, orally, once daily for up to 8 weeks
DRUG	TAK-583	TAK-583 50 mg, tablets, orally, once daily for up to 8 weeks
DRUG	TAK-583	TAK-583 100 mg, tablets, orally, once daily for up to 8 weeks
DRUG	Placebo	TAK-583 placebo-matching tablets, orally, once daily for up to 8 weeks

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-09-18
• Last updated: 2012-02-02

Locations

48 sites across 9 countries: Australia, Bulgaria, Czechia, Germany, Netherlands, Poland, Russia, South Africa, United Kingdom