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.
- Conditions
- Postherpetic neuralgiaMedDRA version: 7.1 Level: LLT Classification code 10019979
- Registration Number
- EUCTR2005-005863-26-GB
- Lead Sponsor
- Takeda Global Research & Development Centre (Europe) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
11.Subjects who have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline.
12.Subjects who have received TAK-583 in a previous clinical study.
13.Subjects who have donated more than 400 mL of blood in the 90 days prior to the beginning of the study.
14.Subjects who have a history of alcohol or illicit drug abuse in the past 2 years
15.Clinically significant abnormal 12 lead ECG. A QTc >450 ms that is confirmed on a repeat ECG is considered cllinically significant
16.Subjects who have skin conditions in the affected dermatome that could alter sensation.
17.Subjects who have taken any excluded substances (prescription or non-prescription) in the timeframe specified in Section 7.3 (Excluded Medications).
18.Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study.
19.The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, sibling) of a study site employee involved in conduct of this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method