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| Name | Class |
|---|---|
| Maruishi Pharmaceutical | INDUSTRY |
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Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia which correspond to the protocol definitions | Definition:
| Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of with a Richmond Agitation-Sedation Sedation Score ≤0 during the study drug infusion | Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days. | |
| Percentage of time with a Richmond Agitation-Sedation Sedation Score =0, -1,-2 during the study drug infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Misa Kawai | Hospira, now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyogo Medical University Hospital | Nishinomiya | Hyōgo | 663-8501 | Japan | ||
| Kagoshima University Hospital |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days. |
| Administration frequency and dosage of additional sedatives | Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days. |
| Administration frequency and dosage of additional analgesics | Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days. |
| Kagoshima |
| Kagoshima-ken |
| 890-8520 |
| Japan |
| Kinki University Hospital | Sayama | Osaka | 589-8511 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Hamamatsu Medical University Hospital | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Nippon Medical School Hospital | Bunkyo-ku | Tokyo | 113-8603 | Japan |
| Jikei University Hospital | Minato-ku | Tokyo | 105-8741 | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Keio University Hospital | Sinjuku-ku | Tokyo | 160-8582 | Japan |
| Yamanashi University Hospital | Chūō | Yamanashi | 409-3898 | Japan |