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

NCT ID: NCT00377598

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 399 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-02-29

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 symptoms, including a deep aching, shooting or burning pain, sensory deficits, hyperalgesia, allodynia, paresthesia, and dysesthesia. Postherpetic neuralgia is more common in the elderly, and it can have a debilitating effect on a patient. The most commonly prescribed treatments are tricyclic antidepressants and anticonvulsants, however these treatments are effective in approximately half of subjects and may also have undesirable side effects (eg, dizziness and somnolence).

TAK-583 is a synthetic compound under development by Takeda Global Research & Development Center, Inc. as a treatment for neuropathic pain and for delaying the progression of diabetic neuropathy.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 Weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs, body height and weight, physical examinations and electrocardiograms.

Conditions

Neuralgia, Postherpetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TAK-583 5 mg QD

Group Type: EXPERIMENTAL

TAK-583

Intervention Type: DRUG

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

TAK-583 25 mg QD

Group Type: EXPERIMENTAL

TAK-583

Intervention Type: DRUG

TAK-583 25 mg, tablets, orally, once daily for up to 8 weeks

TAK-583 50 mg QD

Group Type: EXPERIMENTAL

TAK-583

Intervention Type: DRUG

TAK-583 50 mg, tablets, orally, once daily for up to 8 weeks

TAK-583 100 mg QD

Group Type: EXPERIMENTAL

TAK-583

Intervention Type: DRUG

TAK-583 100 mg, tablets, orally, once daily for up to 8 weeks

Placebo QD

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

TAK-583

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

Intervention Type: DRUG

TAK-583

TAK-583 25 mg, tablets, orally, once daily for up to 8 weeks

Intervention Type: DRUG

TAK-583

TAK-583 50 mg, tablets, orally, once daily for up to 8 weeks

Intervention Type: DRUG

TAK-583

TAK-583 100 mg, tablets, orally, once daily for up to 8 weeks

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

VP Clinical Science

Role: STUDY_DIRECTOR

Takeda Global Research & Development Center

Locations

Sydney, New South Wales, Australia

Kipparing, Queensland, Australia

Maroochydore, Queensland, Australia

Box Hill, Victoria, Australia

Carlton, Victoria, Australia

Fitzroy, Victoria, Australia

Perth, Western Australia, Australia

Sofia, , Bulgaria

Hradec Králové, , Czechia

Moravská Ostrava, , Czechia

Olomouc, , Czechia

Ostrava, , Czechia

Pilsen, , Czechia

Berlin, , Germany

Dresden, , Germany

Frankfurt, , Germany

Görlitz, , Germany

Hamburg, , Germany

Jena, , Germany

Leipzig, , Germany

Magdeburg, , Germany

Schwerin, , Germany

Arnhem, , Netherlands

Breda, , Netherlands

Roosendaal, , Netherlands

Rotterdam, , Netherlands

Stadskanaal, , Netherlands

Utrecht, , Netherlands

Gdansk, , Poland

Lublin, , Poland

Mosina k/Poznania, , Poland

Poznan, , Poland

Kazan', , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Bloemfontein, Free State, South Africa

Pretoria, Gauteng, South Africa

Amanzimtori, KwaZulu-Natal, South Africa

Durban, KwaZulu-Natal, South Africa

Breyten, Mpumalanga, South Africa

Mbombela, Mpumalanga, South Africa

Polokwane, Western Cape, South Africa

Worcester, Western Cape, South Africa

Chichester, , United Kingdom

Darlington, , United Kingdom

Glasgow, , United Kingdom

Plymouth, , United Kingdom

Solihull, , United Kingdom

Countries

Australia; Bulgaria; Czechia; Germany; Netherlands; Poland; Russia; South Africa; United Kingdom

Other Identifiers

2005-005863-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1127-6187

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-583-EC201

Identifier Type: -

Identifier Source: org_study_id