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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00377598




Registration number
NCT00377598
Ethics application status
Date submitted
14/09/2006
Date registered
18/09/2006
Date last updated
2/02/2012

Titles & IDs
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
Secondary ID [1] 0 0
2005-005863-26
Secondary ID [2] 0 0
TAK-583-EC201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuralgia, Postherpetic 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAK-583
Treatment: Drugs - TAK-583
Treatment: Drugs - TAK-583
Treatment: Drugs - TAK-583
Treatment: Drugs - Placebo

Experimental: TAK-583 5 mg QD -

Experimental: TAK-583 25 mg QD -

Experimental: TAK-583 50 mg QD -

Experimental: TAK-583 100 mg QD -

Placebo Comparator: Placebo QD -


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

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

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

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

Treatment: Drugs: Placebo
TAK-583 placebo-matching tablets, orally, once daily for up to 8 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in average daily pain intensity score for the previous 7 days
Timepoint [1] 0 0
Week 8 or Final Visit
Secondary outcome [1] 0 0
Change from baseline to each study visit in average daily pain intensity score for the last 7 days
Timepoint [1] 0 0
At All Visits
Secondary outcome [2] 0 0
Change from baseline in pain assessment as assessed by Short form McGill Pain Questionnaire
Timepoint [2] 0 0
Week 8 or Final Visit
Secondary outcome [3] 0 0
Change from baseline in weekly mean sleep interference scores (assessed on an 11-point numerical scale in the subject's sleep diary)
Timepoint [3] 0 0
Week 8 or Final Visit
Secondary outcome [4] 0 0
Clinician and subject global impression of change using a 7-point scale
Timepoint [4] 0 0
Week 8 or Final Visit
Secondary outcome [5] 0 0
Change from baseline in quality of life as assessed by Short Form-36
Timepoint [5] 0 0
Week 8 or Final Visit
Secondary outcome [6] 0 0
Change from baseline in Profile of Mood States
Timepoint [6] 0 0
Week 8 or Final Visit
Secondary outcome [7] 0 0
Proportions of subjects with at least 30% and 50% reduction from baseline in average daily pain intensity score
Timepoint [7] 0 0
Week 8 or Final Visit

Eligibility
Key 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).
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
399
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Kipparing
Recruitment hospital [3] 0 0
- Maroochydore
Recruitment hospital [4] 0 0
- Box Hill
Recruitment hospital [5] 0 0
- Carlton
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Kipparing
Recruitment postcode(s) [3] 0 0
- Maroochydore
Recruitment postcode(s) [4] 0 0
- Box Hill
Recruitment postcode(s) [5] 0 0
- Carlton
Recruitment postcode(s) [6] 0 0
- Fitzroy
Recruitment postcode(s) [7] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Hradec Kralove
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Moravska Ostrava
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Olomouc
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Ostrava
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Plzen
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
Dresden
Country [9] 0 0
Germany
State/province [9] 0 0
Frankfurt
Country [10] 0 0
Germany
State/province [10] 0 0
Goerlitz
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
Jena
Country [13] 0 0
Germany
State/province [13] 0 0
Leipzig
Country [14] 0 0
Germany
State/province [14] 0 0
Magdeburg
Country [15] 0 0
Germany
State/province [15] 0 0
Schwerin
Country [16] 0 0
Netherlands
State/province [16] 0 0
Arnhem
Country [17] 0 0
Netherlands
State/province [17] 0 0
Breda
Country [18] 0 0
Netherlands
State/province [18] 0 0
Roosendaal
Country [19] 0 0
Netherlands
State/province [19] 0 0
Rotterdam
Country [20] 0 0
Netherlands
State/province [20] 0 0
Stadskanaal
Country [21] 0 0
Netherlands
State/province [21] 0 0
Utrecht
Country [22] 0 0
Poland
State/province [22] 0 0
Gdansk
Country [23] 0 0
Poland
State/province [23] 0 0
Lublin
Country [24] 0 0
Poland
State/province [24] 0 0
Mosina k/Poznania
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Kazan
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Russian Federation
State/province [28] 0 0
St. Petersburg
Country [29] 0 0
South Africa
State/province [29] 0 0
Free State
Country [30] 0 0
South Africa
State/province [30] 0 0
Gauteng
Country [31] 0 0
South Africa
State/province [31] 0 0
Kwa-Zulu Natal
Country [32] 0 0
South Africa
State/province [32] 0 0
Mpumalanga
Country [33] 0 0
South Africa
State/province [33] 0 0
Western Cape
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Chichester
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Darlington
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Glasgow
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Plymouth
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Solihull

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00377598
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
VP Clinical Science
Address 0 0
Takeda Global Research & Development Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries