Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients
This study has been completed.
Sponsor:
Maruho Co., Ltd.
Information provided by:
Maruho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00884169
First received: April 17, 2009
Last updated: November 2, 2010
Last verified: November 2010
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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
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 June 18, 2013