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Sponsors and Collaborators: |
Hospira, Inc. Maruishi Pharmaceutical |
Information provided by: | Hospira, Inc. |
ClinicalTrials.gov Identifier: | NCT00526760 |
Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24hrs sedation.
Condition | Intervention | Phase |
Sedation |
Drug: Dexmedetomidine |
Phase III |
ChemIDplus related topics: | Dexmedetomidine Dexmedetomidine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Open-Label Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects Requiring Greater Than 24 Hours of Continues Sedation |
Estimated Enrollment: | 80 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2008 |
According to the current dexmedetomidine indication, the duration of dexmedetomidine administration is limited within 24 hours. However, there is a strong demand from the medical specialists for continued administration of dexmedetomidine in excess of 24 hours in the medical practice because a large number of patients require sedation for more than 24 hours in ICU. To meet such clinical demand, it was planned to conduct a phase III long-term administration study of dexmedetomidine to obtain the approval on the infusion of dexmedetomidine for more than 24 hours.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Misa Kawai | 81-6-4560-2002 | misa.kawai@hospira.com |
Japan, Hyogo | |||||
Hyogo Medical University Hospital | Not yet recruiting | ||||
Nishinomiya-City, Hyogo, Japan, 663-8501 | |||||
Principal Investigator: Shinichi Nishi, Professor | |||||
Japan, Kagoshima | |||||
Kagoshima University Hospital | Not yet recruiting | ||||
Kagoshima-City, Kagoshima, Japan, 890-8520 | |||||
Principal Investigator: Yasuyuki Kakihana, Associate professor | |||||
Japan, Osaka | |||||
Osaka University Hospital | Not yet recruiting | ||||
Suita-City, Osaka, Japan, 565-0871 | |||||
Principal Investigator: Yuji Fujino, Associate professor | |||||
Kinki University Hospital | Not yet recruiting | ||||
Osakasayama-City, Osaka, Japan, 589-8511 | |||||
Principal Investigator: Yasuhiro Shiokawa, Associate professor | |||||
Japan, Sizuoka | |||||
Hamamatsu Madical University Hospital | Not yet recruiting | ||||
Hamamatsu-City, Sizuoka, Japan, 431-3192 | |||||
Principal Investigator: Matsuyuki Doi, Associate professor | |||||
Japan, Tokyo | |||||
Tokyo Women's Medical University Hospital | Not yet recruiting | ||||
Shinjuku-ku, Tokyo, Japan, 162-8666 | |||||
Principal Investigator: Makoto Ozaki, Professor | |||||
Nippon Medical School Hospital | Not yet recruiting | ||||
Bunkyo-ku, Tokyo, Japan, 113-8603 | |||||
Principal Investigator: Keiji Tanaka, Professor | |||||
Jikei University Hospital | Not yet recruiting | ||||
Minato-ku, Tokyo, Japan, 105-8741 | |||||
Principal Investigator: Masanori Takinami, Pofessor | |||||
Keio University Hospital | Not yet recruiting | ||||
Sinjuku-ku, Tokyo, Japan, 160-8582 | |||||
Principal Investigator: Junzo Takeda, Professor | |||||
Japan, Yamanashi | |||||
Yamanashi University Hospital | Not yet recruiting | ||||
Chuo-city, Yamanashi, Japan, 409-3898 | |||||
Principal Investigator: Kenichi Matsuda, Professor |
Hospira, Inc. |
Maruishi Pharmaceutical |
Study Director: | Misa Kawai | Hospira, Inc. |
Study ID Numbers: | DEX-402 |
First Received: | September 5, 2007 |
Last Updated: | September 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00526760 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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