A Phase II, double blind, placebo controlled, dose-ranging study in patients with post herpetic neuralgia (PHN) to evaluate the efficacy, safety, tolerability and pharmacokinetics of four doses of TAK-583, compared with placebo.

Takeda Global Research & Development Centre (Europe) Ltd0 sites0 target enrollmentMarch 3, 2006

Overview

No summary available.

Registry

who.int

Start Date

March 3, 2006

End Date

February 5, 2008

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Takeda Global Research & Development Centre (Europe) Ltd

•1\.Male and female subjects with PHN whose pain has been present for \>3 months following healing of the herpes zoster rash.
•2\.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.
•3\.Subjects aged 50 years and above.
•4\.The female subject is postmenopausal.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•1\.Malignancy within the past 2 years with the exception of basal cell carcinoma.
•2\.Subjects who have undergone neurolytic or neurosurgical therapy for PHN.
•3\.Clinically significant, actively treated or unstable hepatic, biliary, respiratory, renal, rheumatologic, or hematologic illnesses, or unstable cardiovascular disease as assessed by the investigator.
•4\.WBC \<2500, ANC \<1500, platelets \<100,000; ALT, AST or alkaline phosphatase \>1\.5x ULN; total bilirubin \=1\.2x ULN (excluding Gilbert’s Disease); predicted GFR using MDRD formula \= 45 mL/min.
•5\.Subjects with \> 5 RBCs per high\-power field on urinalysis.
•6\.Subjects with an albumin/creatinine ratio in an untimed (spot”) morning urine specimen \>ULN.
•7\.Subjects who are immunocompromised or have clinically significant haematological abnormalities.
•8\.Subjects with a history of HIV infection.
•9\.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.
•10\.Subjects having other severe pain which may impair the self assessment of the pain due to PHN.