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

NCT00377598 | Completed Phase 2

• 3 other identifiers: TAK-583-EC2012005-005863-26U1111-1127-6187
• Study Type: interventional
• Target: 399
• Locations: 9 countries
• Sites: 48

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.

Conditions

Neuralgia, Postherpetic

Keywords

Herpes Zoster; Neuralgia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in average daily pain intensity score for the previous 7 days

  Week 8 or Final Visit

Secondary Outcomes (7)

• Change from baseline to each study visit in average daily pain intensity score for the last 7 days

  At All Visits

• Change from baseline in pain assessment as assessed by Short form McGill Pain Questionnaire

  Week 8 or Final Visit

• Change from baseline in weekly mean sleep interference scores (assessed on an 11-point numerical scale in the subject's sleep diary)

  Week 8 or Final Visit

• Clinician and subject global impression of change using a 7-point scale

  Week 8 or Final Visit

• Change from baseline in quality of life as assessed by Short Form-36

  Week 8 or Final Visit

Study Arms (5)

TAK-583 5 mg QD

EXPERIMENTAL

Drug: TAK-583

TAK-583 25 mg QD

EXPERIMENTAL

Drug: TAK-583

TAK-583 50 mg QD

EXPERIMENTAL

Drug: TAK-583

TAK-583 100 mg QD

EXPERIMENTAL

Drug: TAK-583

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAK-583 DRUG

TAK-583 5 mg, tablets, orally, once daily for up to 8 weeks

TAK-583 5 mg QD

Placebo DRUG

TAK-583 placebo-matching tablets, orally, once daily for up to 8 weeks

Placebo QD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (48)

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Sydney, New South Wales, Australia

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Kipparing, Queensland, Australia

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Maroochydore, Queensland, Australia

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Box Hill, Victoria, Australia

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Carlton, Victoria, Australia

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Fitzroy, Victoria, Australia

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Perth, Western Australia, Australia

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Sofia, Bulgaria

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Hradec Králové, Czechia

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Moravská Ostrava, Czechia

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Olomouc, Czechia

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Ostrava, Czechia

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Pilsen, Czechia

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Berlin, Germany

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Dresden, Germany

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Frankfurt, Germany

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Görlitz, Germany

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Hamburg, Germany

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Jena, Germany

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Leipzig, Germany

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Magdeburg, Germany

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Schwerin, Germany

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Arnhem, Netherlands

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Breda, Netherlands

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Roosendaal, Netherlands

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Rotterdam, Netherlands

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Stadskanaal, Netherlands

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Utrecht, Netherlands

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Gdansk, Poland

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Lublin, Poland

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Mosina k/Poznania, Poland

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Poznan, Poland

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Kazan', Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Bloemfontein, Free State, South Africa

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Pretoria, Gauteng, South Africa

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Amanzimtori, KwaZulu-Natal, South Africa

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Durban, KwaZulu-Natal, South Africa

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Breyten, Mpumalanga, South Africa

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Mbombela, Mpumalanga, South Africa

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Polokwane, Western Cape, South Africa

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Worcester, Western Cape, South Africa

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Chichester, United Kingdom

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Darlington, United Kingdom

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Glasgow, United Kingdom

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Plymouth, United Kingdom

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Solihull, United Kingdom

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MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster; Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• VP Clinical Science

  Takeda Global Research & Development Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: October 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 2, 2012

Record last verified: 2012-01

Locations

BU (1); DE (9); CZ (5); RU (3); AU (7); GB (5); ZA (8); NL (6); PL (4)