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

April 17, 2009
November 2, 2010
July 2009
Not Provided
Severity of plaque psoriasis
Same as current
Complete list of historical versions of study NCT00884169 on ClinicalTrials.gov Archive Site
Investigator and Patient overall assessment
Same as current
Not Provided
Not Provided
 
Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients
Not Provided

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Masking: Double-Blind
Plaque Psoriasis
  • Drug: M518101
    Proper quantity twice a day
  • Drug: placebo
    Proper quantity twice a day
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
December 2009
Not Provided

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.
Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00884169
M518101-EU03
Not Provided
R&D Administration Department, Maruho Co.,Ltd ・Kyoto R&D Center
Maruho Co., Ltd.
Not Provided
Not Provided
Maruho Co., Ltd.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP