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An Open-Label, Multi-Center Trial in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis

NCT ID: NCT00725348

Last Updated: 2011-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-12-31

Brief Summary

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This is a study of a new oral drug used for the treatment of psoriasis. All subjects will get active medication, there is no placebo arm.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

R115866

Group Type EXPERIMENTAL

Talarozole

Intervention Type DRUG

1.0 mg oral dose per day

Interventions

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Talarozole

1.0 mg oral dose per day

Intervention Type DRUG

Other Intervention Names

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Rambazole R115866

Eligibility Criteria

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Inclusion Criteria

* Male or female of non-childbearing potential (at least 2 years post-menopausal or undergone successful surgical sterilization at least 1 year before inclusion)
* Presence of moderate to severe plaque psoriasis with a PASI of at least 5

Exclusion Criteria

* Pustular, guttate or other non-plaque forms of psoriasis or psoriatic arthritis
* Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
* History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
* Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc \>470 ms in females or \>450 ms in males
* Use of vitamin A (\>1000 µg/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroidal anti-inflammatory drugs, non-potassium-sparing diuretics
* Previous use of any systemic immunomodulatory therapy (biologicals) or psoriasis vaccine
* Use of other systemic therapy for psoriasis (e.g. PUVA, systemic steroids, cyclosporin A, methotrexate, retinoids) within four weeks prior to Visit 2
* Use of UV therapy or excessive UV exposure or topical therapy for psoriasis other than bland emollients within two weeks prior to Visit 2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stiefel, a GSK Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. P. van de Kerkhof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nijmegen, Maastricht, The Netherlands

Locations

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Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

Universitair Medisch Centrum Nijmegen Sint Radboud

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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BT0700NED001

Identifier Type: -

Identifier Source: org_study_id