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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

Inclusion Criteria:

• Male and female subjects with postherpetic neuralgia whose pain has been present for >3 months following healing of the herpes zoster rash.

• Subjects with an mean pain intensity score of 4 or more (determined from at least 4 daily recordings of pain intensity on an 11-point numerical scale over the preceding 7 days) during the baseline phase.

• Subjects aged 50 years and above.

• The female subject is not of child-bearing potential (eg, sterilized, postmenopausal).

Exclusion Criteria:

• Malignancy within the past 2 years with the exception of basal cell carcinoma.

• Subjects who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.

• Clinically significant, actively treated or unstable hepatic, biliary, respiratory, renal, rheumatologic, or hematologic illnesses, or unstable cardiovascular disease as assessed by the investigator.

• WBC less than 2500, ANC less than 1500, platelets less than 100,000; ALT, AST or alkaline phosphatase greater than 1.5x ULN; total bilirubin greater than or equal to 1.2 times the upper limit of normal (excluding Gilbert's Disease); predicted GFR using Cockcroft and Gault formula less than or equal to 40 mL/min.

• Subjects with greater than 5 red blood cells per high-power field on urinalysis.

• Subjects with an albumin/creatinine ratio in an untimed ("spot") morning urine specimen greater than the upper limit of normal.

• Subjects who are immunocompromised or have clinically significant haematological abnormalities.

• Subjects with a history of HIV infection.

• Subjects with a positive hepatitis panel (including hepatitis B surface antigen, antibody to hepatitis B core antigen, antibody to hepatitis B surface antigen, or antibody to hepatitis C virus), except subjects with positive antibodies to hepatitis B surface antigen who have received hepatitis B vaccination and who have no history of serological evidence of liver disease.

• Subjects having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.

• Subjects who have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline.

• Subjects who have received TAK-583 in a previous clinical study.

• Subjects who have donated more than 400 mL of blood in the 90 days prior to the beginning of the study.

• Subjects who have a history of alcohol or illicit drug abuse in the past 2 years

• Clinically significant abnormal 12 lead electrocardiogram, including QT interval corrected for heart rate greater than 450 ms that is confirmed on a repeat electrocardiogram.