A Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-583 in Subjects With Postherpetic Neuralgia (PHN)

The purpose of the study is to assess the safety and ability of TAK-583 to relieve pain in subjects with PHN, compared with placebo.

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.

Conditions

Neuralgia, Postherpetic

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• Change from baseline in average daily pain intensity score.

PHN can be defined as neuropathic pain which is still present 3 months following healing of the Herpes Zoster rash. Subjects who fulfill this definition of PHN will be eligible for entry into the study. All eligible subjects will enter a baseline phase (7 days) of the study; during this time subjects will record a daily pain score and a daily sleep interference score. Following the baseline phase, eligible subjects will be randomized to receive either TAK-583 or placebo. Subjects will receive study drug for 8 weeks, including 4 return visits to the clinic for assessments. After treatment, subjects will enter a 7-day follow up phase after which the subjects will return for their last visit.

Study Start

October 2006

Eligibility & Criteria

Ages Eligible for Study: 50 Years and above
Genders Eligible for Study: Both

Inclusion Criteria:

• Male and female subjects with PHN whose pain has been present for >3 months following healing of the herpes zoster rash.
• Subjects aged 50 years and above.
• The female subject is not of childbearing potential (eg, sterilized, postmenopausal).

Exclusion Criteria:

• Subjects who have undergone neurolytic or neurosurgical therapy for PHN.
• Subjects who are immunocompromized or have clinically significant haematological abnormalities.
• Subjects having other severe pain which may impair the self assessment of the pain due to PHN.
• Subjects who have skin conditions in the affected dermatome that could alter sensation.

Total Enrolment

400

Contact Details

Samantha J Good, PhD +44 207759 5000 Ext. 5075 sgood@tgrd.com
Jennifer Gillard, BSc +44 207759 5000 Ext. 5058 jgillard@tgrd.com

New South Wales
Sydney, New South Wales, Australia; Recruiting
Queensland
Maroochydore, Queensland, Australia; Recruiting
Kipparing, Queensland, Australia; Recruiting
Victoria
Box Hill, Victoria, Australia; Recruiting
Fitzroy, Victoria, Australia; Recruiting
Carlton, Victoria, Australia; Recruiting
Western Australia
Perth, Western Australia, Australia; Recruiting