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

This study has been completed.
Sponsor:
Collaborator:
Maruishi Pharmaceutical
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00526760
First received: September 5, 2007
Last updated: June 15, 2010
Last verified: June 2010
  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

Resource links provided by NLM:


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
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Sponsors and Collaborators
Hospira, Inc.
Maruishi Pharmaceutical
Investigators
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 August 20, 2014