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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Double Blind, Placebo Controlled, Dose-Ranging Study in Subjects With Postherpetic Neuralgia (PHN) to Evaluate the Efficacy, Safety

Brief 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 Summary:

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.


Sponsor: Takeda

Current Primary Outcome: Change from Baseline in average daily pain intensity score for the previous 7 days [ Time Frame: Week 8 or Final Visit ]

Original Primary Outcome: Change from baseline in average daily pain intensity score.

Current Secondary Outcome:

  • Change from baseline to each study visit in average daily pain intensity score for the last 7 days [ Time Frame: At All Visits ]
  • Change from baseline in pain assessment as assessed by Short form McGill Pain Questionnaire [ Time Frame: Week 8 or Final Visit ]
  • Change from baseline in weekly mean sleep interference scores (assessed on an 11-point numerical scale in the subject's sleep diary) [ Time Frame: Week 8 or Final Visit ]
  • Clinician and subject global impression of change using a 7-point scale [ Time Frame: Week 8 or Final Visit ]
  • Change from baseline in quality of life as assessed by Short Form-36 [ Time Frame: Week 8 or Final Visit ]
  • Change from baseline in Profile of Mood States [ Time Frame: Week 8 or Final Visit ]
  • Proportions of subjects with at least 30% and 50% reduction from baseline in average daily pain intensity score [ Time Frame: Week 8 or Final Visit ]


Original Secondary Outcome:

Information By: Takeda

Dates:
Date Received: September 14, 2006
Date Started: October 2006
Date Completion:
Last Updated: January 31, 2012
Last Verified: January 2012