An Open-Label, Multi-Center Trial in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis
This study has been completed.
Sponsor:
Stiefel, a GSK Company
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00725348
First received: July 17, 2008
Last updated: September 23, 2011
Last verified: July 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: Talarozole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multi-Center Pilot Trial to Assess the Efficacy and Safety of Oral R115866 in the Treatment of Subjects With Moderate to Severe Plaque Type Psoriasis |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- PASI Scores [ Time Frame: Various Visits ] [ Designated as safety issue: No ]
| Enrollment: | 19 |
| Study Start Date: | April 2004 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
R115866
|
Drug: Talarozole
1.0 mg oral dose per day
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725348
Locations
| Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands | |
| Universitair Medisch Centrum Nijmegen Sint Radboud | |
| Nijmegen, Netherlands | |
Sponsors and Collaborators
Stiefel, a GSK Company
Investigators
| Principal Investigator: | Prof. P. van de Kerkhof, MD, PhD | University of Nijmegen, Maastricht, The Netherlands |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline ( Stiefel, a GSK Company ) |
| ClinicalTrials.gov Identifier: | NCT00725348 History of Changes |
| Other Study ID Numbers: | BT0700NED001 |
| Study First Received: | July 17, 2008 |
| Last Updated: | September 23, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by GlaxoSmithKline:
|
Psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013