Clinical trial NCT00377598: Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic Neuralgia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Neuralgia, Postherpetic
Keywords: Herpes Zoster
Neuralgia
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-09-18
Enrollment: 399
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in average daily pain intensity score for the previous 7 days
timeFrame: Week 8 or Final Visit
Secondary outcomes:
measure: Change from baseline to each study visit in average daily pain intensity score for the last 7 days
timeFrame: At All Visits
measure: Change from baseline in pain assessment as assessed by Short form McGill Pain Questionnaire
timeFrame: Week 8 or Final Visit
measure: Change from baseline in weekly mean sleep interference scores (assessed on an 11-point numerical scale in the subject's sleep diary)
timeFrame: Week 8 or Final Visit
measure: Clinician and subject global impression of change using a 7-point scale
timeFrame: Week 8 or Final Visit
measure: Change from baseline in quality of life as assessed by Short Form-36
timeFrame: Week 8 or Final Visit
measure: Change from baseline in Profile of Mood States
timeFrame: Week 8 or Final Visit
measure: Proportions of subjects with at least 30% and 50% reduction from baseline in average daily pain intensity score
timeFrame: Week 8 or Final Visit
Other outcomes:
Locations:
city: Sydney
country: Australia
state: New South Wales
city: Kipparing
country: Australia
state: Queensland
city: Maroochydore
country: Australia
state: Queensland
city: Box Hill
country: Australia
state: Victoria
city: Carlton
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Sofia
country: Bulgaria
city: Hradec Kralove
country: Czech Republic
city: Moravska Ostrava
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Plzen
country: Czech Republic
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Frankfurt
country: Germany
city: Goerlitz
country: Germany
city: Hamburg
country: Germany
city: Jena
country: Germany
city: Leipzig
country: Germany
city: Magdeburg
country: Germany
city: Schwerin
country: Germany
city: Arnhem
country: Netherlands
city: Breda
country: Netherlands
city: Roosendaal
country: Netherlands
city: Rotterdam
country: Netherlands
city: Stadskanaal
country: Netherlands
city: Utrecht
country: Netherlands
city: Gdansk
country: Poland
city: Lublin
country: Poland
city: Mosina k/Poznania
country: Poland
city: Poznan
country: Poland
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Bloemfontein
country: South Africa
state: Free State
city: Pretoria
country: South Africa
state: Gauteng
city: Amanzimtori
country: South Africa
state: Kwa-Zulu Natal
city: Durban
country: South Africa
state: Kwa-Zulu Natal
city: Breyten
country: South Africa
state: Mpumalanga
city: Nelspruit
country: South Africa
state: Mpumalanga
city: Polokwane
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
city: Chichester
country: United Kingdom
city: Darlington
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Solihull
country: United Kingdom
Study officials:
affiliation: Takeda Global Research & Development Center
name: VP Clinical Science
role: STUDY_DIRECTOR
References: