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

Sedation Clinical Trial

Official title:

A Phase 3, Open-Label Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects Requiring Greater Than 24 Hours of Continuous Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526760
• Other study ID #: DEX-402
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2007
• Last updated: June 29, 2015
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: June 2015
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 American Society of Anesthesiologists (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 central nervous system (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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
Japan	Nippon Medical School Hospital	Bunkyo-ku	Tokyo
Japan	Yamanashi University Hospital	Chuo-city	Yamanashi
Japan	Hamamatsu Medical University Hospital	Hamamatsu-City	Shizuoka
Japan	Kagoshima University Hospital	Kagoshima-City	Kagoshima
Japan	Jikei University Hospital	Minato-ku	Tokyo
Japan	Hyogo Medical University Hospital	Nishinomiya-City	Hyogo
Japan	Kinki University Hospital	Osakasayama-City	Osaka
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Keio University Hospital	Sinjuku-ku	Tokyo
Japan	Osaka University Hospital	Suita-City	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Hospira, Inc.	Maruishi Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia which correspond to the protocol definitions	Definition: Hypotension: dosing start or dose increase of vasopressor drug or use of fluid bolus =500 mL within 1 hour resulting from SBP<60mmHg, DBP<40mmHg or =50% lower than baseline.; Hypertension: dosing start or dose increase of intravenous anti-hypertensive medication resulting from SBP>160, DBP>100 or. =50% higher than baseline.; Bradycardia: dosing start or dose increase of positive chronotropic medication or use of pacemaker resulting from heart rate <40bpm or =50% lower than baseline.	Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum =28 days.	Yes
Secondary	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.	No
Secondary	Percentage of time with a Richmond Agitation-Sedation Sedation Score =0, -1,-2 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.	No
Secondary	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.	No
Secondary	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.	No