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Neuralgia, PostherpeticPhase 2/3NCT00377598

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

A Phase 2/3 study testing TAK-583 in people with Neuralgia, Postherpetic, run by Takeda at 48 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Neuralgia, Postherpetic
What is being tested?
TAK-583
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
399 participants
Where
48 sitesin 9 countries
Study dates
Oct 2006to Feb 2008
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

48 sites in 9 countries.

48 sites in 9 countries

Germany9 sites

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Frankfurt

  • Study site

    Görlitz

  • Study site

    Hamburg

  • Study site

    Jena

  • Study site

    Leipzig

  • Study site

    Magdeburg

  • Study site

    Schwerin

Other trials in Germany

South Africa8 sites

  • Study site

    Amanzimtori, KwaZulu-Natal

  • Study site

    Bloemfontein, Free State

  • Study site

    Breyten, Mpumalanga

  • Study site

    Durban, KwaZulu-Natal

  • Study site

    Mbombela, Mpumalanga

  • Study site

    Polokwane, Western Cape

  • Study site

    Pretoria, Gauteng

  • Study site

    Worcester, Western Cape

Other trials in South Africa

Australia7 sites

  • Study site

    Box Hill, Victoria

  • Study site

    Carlton, Victoria

  • Study site

    Fitzroy, Victoria

  • Study site

    Kipparing, Queensland

  • Study site

    Maroochydore, Queensland

  • Study site

    Perth, Western Australia

  • Study site

    Sydney, New South Wales

Other trials in Australia

Netherlands6 sites

  • Study site

    Arnhem

  • Study site

    Breda

  • Study site

    Roosendaal

  • Study site

    Rotterdam

  • Study site

    Stadskanaal

  • Study site

    Utrecht

Other trials in Netherlands

Czechia5 sites

  • Study site

    Hradec Králové

  • Study site

    Moravská Ostrava

  • Study site

    Olomouc

  • Study site

    Ostrava

  • Study site

    Pilsen

Other trials in Czechia

United Kingdom5 sites

  • Study site

    Chichester

  • Study site

    Darlington

  • Study site

    Glasgow

  • Study site

    Plymouth

  • Study site

    Solihull

Other trials in United Kingdom

Poland4 sites

  • Study site

    Gdansk

  • Study site

    Lublin

  • Study site

    Mosina k/Poznania

  • Study site

    Poznan

Other trials in Poland

Russia3 sites

  • Study site

    Kazan'

  • Study site

    Moscow

  • Study site

    Saint Petersburg

Other trials in Russia

Bulgaria1 site

  • Study site

    Sofia

Other trials in Bulgaria

About this study

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

The purpose of this study is to evaluate the efficacy of TAK-583, once daily (QD), in relieving pain in subjects with postherpetic neuralgia.

Read the 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.

Being tested
TAK-583, Placebo
Keywords
Herpes Zoster, Neuralgia, Drug Therapy
Medical subject headings
Neuralgia, Postherpetic, Herpes Zoster, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-583Drug

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

  • TAK-583Drug

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

  • TAK-583Drug

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

  • TAK-583Drug

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

  • PlaceboDrug

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

Study groups in NCT00377598
Study groupRoleWhat they receive
TAK-583 5 mg QDExperimentalNot described
Receives: Drug: TAK-583
TAK-583 25 mg QDExperimentalNot described
Receives: Drug: TAK-583
TAK-583 50 mg QDExperimentalNot described
Receives: Drug: TAK-583
TAK-583 100 mg QDExperimentalNot described
Receives: Drug: TAK-583
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 8 or Final Visit

Secondary outcomes (7)

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

    Measured: At All Visits

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

    Measured: Week 8 or Final Visit

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

    Measured: Week 8 or Final Visit

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

    Measured: Week 8 or Final Visit

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

    Measured: Week 8 or Final Visit

  6. Change from baseline in Profile of Mood States

    Measured: Week 8 or Final Visit

  7. Proportions of subjects with at least 30% and 50% reduction from baseline in average daily pain intensity score

    Measured: Week 8 or Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00377598
Sponsor's protocol ID
TAK-583-EC201
Other IDs
2005-005863-26, U1111-1127-6187, 2005
Status last verified
Jan 2012
First submitted
14 Sep 2006
Last updated
2 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TAK-583 in people with Neuralgia, Postherpetic, run by Takeda at 48 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Germany, South Africa, Australia, Netherlands, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in average daily pain intensity score for the previous 7 days (time frame: Week 8 or Final Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00377598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.

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