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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00377598
• Date of registration: 14/09/2006
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic Neuralgia
• Scientific 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
• Date of first enrolment: October 2006
• Target sample size: 399
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00377598
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Bulgaria, Czech Republic, Germany, Netherlands, Poland, Russian Federation, South Africa, United Kingdom

Contacts

• Name: VP Clinical Science
• Affiliation: Takeda Global Research & Development Center

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Neuralgia, Postherpetic

Intervention(s)

Drug: TAK-583

Drug: Placebo

Primary Outcome(s)

Change from Baseline in average daily pain intensity score for the previous 7 days [Time Frame: Week 8 or Final Visit]

Secondary Outcome(s)

Change from baseline in weekly mean sleep interference scores (assessed on an 11-point numerical scale in the subject's sleep diary) [Time Frame: Week 8 or Final Visit]

Change from baseline to each study visit in average daily pain intensity score for the last 7 days [Time Frame: At All Visits]

Proportions of subjects with at least 30% and 50% reduction from baseline in average daily pain intensity score [Time Frame: Week 8 or Final Visit]

Change from baseline in pain assessment as assessed by Short form McGill Pain Questionnaire [Time Frame: Week 8 or Final Visit]

Change from baseline in Profile of Mood States [Time Frame: Week 8 or Final Visit]

Change from baseline in quality of life as assessed by Short Form-36 [Time Frame: Week 8 or Final Visit]

Clinician and subject global impression of change using a 7-point scale [Time Frame: Week 8 or Final Visit]

Secondary ID(s)

2005-005863-26

U1111-1127-6187

TAK-583-EC201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors