Status:
COMPLETED
Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic Neuralgia
Lead Sponsor:
Takeda
Conditions:
Neuralgia, Postherpetic
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
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 Description
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 sympto...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT00377598
Start Date
October 1 2006
End Date
February 1 2008
Last Update
February 2 2012
Active Locations (48)
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1
Sydney, New South Wales, Australia
2
Kipparing, Queensland, Australia
3
Maroochydore, Queensland, Australia
4
Box Hill, Victoria, Australia