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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00884169
Other study ID # M518101-EU03
Secondary ID
Status Completed
Phase Phase 2
First received April 17, 2009
Last updated November 2, 2010
Start date July 2009
Est. completion date December 2009

Study information

Verified date November 2010
Source Maruho Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Hungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlPoland: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date December 2009
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Masking: Double-Blind


Related Conditions & MeSH terms


Intervention

Drug:
M518101
Proper quantity twice a day
placebo
Proper quantity twice a day

Locations

Country Name City State
United Kingdom St Thomas' Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Maruho Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of plaque psoriasis
Secondary Investigator and Patient overall assessment
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