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Long-Term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects

This study is not yet open for participant recruitment.
Verified by Hospira, Inc., September 2007

Sponsors and Collaborators: Hospira, Inc.
Maruishi Pharmaceutical
Information provided by: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT00526760
  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 III

ChemIDplus related topics:   Dexmedetomidine    Dexmedetomidine hydrochloride   

U.S. FDA Resources

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

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia, which correspond to the protocol definitions [ Time Frame: >24hours and ≤28days ]

Secondary Outcome Measures:
  • 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
Estimated Study Completion Date:   June 2008

Detailed Description:

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

Criteria

Inclusion Criteria:

  1. 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.
  2. Patient is male or female, at least 20 years of age.
  3. In case of surgical ICU patient, who is in condition of ASA I to III Class preoperatively.
  4. Patient is on mechanical ventilation and anticipated to require sedation more than 24 hours following a surgery.
  5. If patient is female with child bearing potential, she is to be non-pregnant, and not lactating.

Exclusion Criteria:

  1. Patient has serious CNS trauma.
  2. Patient requires the use of neuromuscular blocking agents after admission to ICU, except for the insertion of the endotracheal tube.
  3. Patient is hospitalized for drug overdose within the last 30 days.
  4. Patient in whom alpha-2 antagonists or alpha-2 agonists are contraindicated.
  5. Patient is currently being treated or has been treated within the last 30 days with alpha-2 agonist or antagonist.
  6. Patient has participated in a trial with any experimental drug within 30 days prior to admission to the ICU.
  7. Terminally ill patient, whose life duration expectancy is no more or around 30 days.
  8. Patient is considered unable to undergo any procedure required by the protocol.
  9. Patient with excessive bleeding which will likely require surgery.
  10. 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526760

Contacts
Contact: Misa Kawai     81-6-4560-2002     misa.kawai@hospira.com    

Locations
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            

Sponsors and Collaborators
Hospira, Inc.
Maruishi Pharmaceutical

Investigators
Study Director:     Misa Kawai     Hospira, Inc.    
  More Information


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

Keywords provided by Hospira, Inc.:
Dexmedetomidine, Sedation, Long-term, Phase 3  

Study placed in the following topic categories:
Dexmedetomidine

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Adrenergic Agonists
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2008




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