Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia, which correspond to the protocol definitions [ Time Frame: >24hours and ≤28days ]
- 1) Percentage of time spent Richmond Agitation-Sedation Sedation Score ≤0 during the study drug infusion 2) Percentage of time spent Richmond Agitation-Sedation Sedation Score =0, -1,-2 during the study drug infusion 3) Adverse events [ Time Frame: >24hours and ≤28days ]
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient or legally acceptable representative (if acceptable by Institutional Review Board/Ethics Committee) has signed and dated the Informed Consent after the study had been fully explained.
- Patient is male or female, at least 20 years of age.
- In case of surgical ICU patient, who is in condition of ASA I to III Class preoperatively.
- Patient is on mechanical ventilation and anticipated to require sedation more than 24 hours following a surgery.
- If patient is female with child bearing potential, she is to be non-pregnant, and not lactating.
Exclusion Criteria:
- Patient has serious CNS trauma.
- Patient requires the use of neuromuscular blocking agents after admission to ICU, except for the insertion of the endotracheal tube.
- Patient is hospitalized for drug overdose within the last 30 days.
- Patient in whom alpha-2 antagonists or alpha-2 agonists are contraindicated.
- Patient is currently being treated or has been treated within the last 30 days with alpha-2 agonist or antagonist.
- Patient has participated in a trial with any experimental drug within 30 days prior to admission to the ICU.
- Terminally ill patient, whose life duration expectancy is no more or around 30 days.
- Patient is considered unable to undergo any procedure required by the protocol.
- Patient with excessive bleeding which will likely require surgery.
- In the Investigator's opinion, patient has any symptom or factor, which might increase risk to the patient or preclude obtaining satisfactory study data.
Contacts and Locations| Japan | |
| Hyogo Medical University Hospital | |
| Nishinomiya-City, Hyogo, Japan, 663-8501 | |
| Kagoshima University Hospital | |
| Kagoshima-City, Kagoshima, Japan, 890-8520 | |
| Kinki University Hospital | |
| Osakasayama-City, Osaka, Japan, 589-8511 | |
| Osaka University Hospital | |
| Suita-City, Osaka, Japan, 565-0871 | |
| Hamamatsu Madical University Hospital | |
| Hamamatsu-City, Sizuoka, Japan, 431-3192 | |
| Nippon Medical School Hospital | |
| Bunkyo-ku, Tokyo, Japan, 113-8603 | |
| Jikei University Hospital | |
| Minato-ku, Tokyo, Japan, 105-8741 | |
| Tokyo Women's Medical University Hospital | |
| Shinjuku-ku, Tokyo, Japan, 162-8666 | |
| Keio University Hospital | |
| Sinjuku-ku, Tokyo, Japan, 160-8582 | |
| Yamanashi University Hospital | |
| Chuo-city, Yamanashi, Japan, 409-3898 | |
| Study Director: | Misa Kawai | Hospira, Inc. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00526760 History of Changes |
| Other Study ID Numbers: | DEX-402 |
| Study First Received: | September 5, 2007 |
| Last Updated: | June 15, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Hospira, Inc.:
|
Dexmedetomidine, Sedation, Long-term, Phase 3 |
Additional relevant MeSH terms:
|
Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013