Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients

This study has been completed.
Sponsor:
Information provided by:
Maruho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00884169
First received: April 17, 2009
Last updated: November 2, 2010
Last verified: November 2010
  Purpose

This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.


Condition Intervention Phase
Plaque Psoriasis
Drug: M518101
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by Maruho Co., Ltd.:

Primary Outcome Measures:
  • Severity of plaque psoriasis

Secondary Outcome Measures:
  • Investigator and Patient overall assessment

Study Start Date: July 2009
Estimated Study Completion Date: December 2009
Intervention Details:
    Drug: M518101
    Proper quantity twice a day
    Drug: placebo
    Proper quantity twice a day
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Who are able and willing to give signed informed consent
  • Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator.
  • Who have less than 20% of body surface area (BSA) afflicted with plaques
  • Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

  • Who have a history of allergy to vitamin D3 derivative preparations.
  • Who have a history of relevant drug hypersensitivity.
  • Who have a history of contact dermatitis induced by a topical medicine.
  • Who are pregnant or lactating.
  • Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
  • Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
  • Whose serum calcium levels exceed the upper limit of reference range
  • Who have used any investigational medicinal product and/or participated in any clinical study within 24 weeks
  • Who have been treated with systemic therapy within 8 weeks
  • Who have been treated with biologics within 12 weeks
  • Who have been treated with topical therapy during the wash-out and lead-in period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884169

Locations
United Kingdom
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Maruho Co., Ltd.
  More Information

No publications provided

Responsible Party: R&D Administration Department, Maruho Co.,Ltd ・Kyoto R&D Center
ClinicalTrials.gov Identifier: NCT00884169     History of Changes
Other Study ID Numbers: M518101-EU03
Study First Received: April 17, 2009
Last Updated: November 2, 2010
Health Authority: Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014