Clinical trial NCT00526760: Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation
Keywords: Dexmedetomidine, Sedation, Long-term, Phase 3
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Maruishi Pharmaceutical
First posted: 2007-09-10
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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 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.

Primary outcomes:
measure: Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia which correspond to the protocol definitions
timeFrame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Secondary outcomes:
measure: Percentage of with a Richmond Agitation-Sedation Sedation Score ≤0 during the study drug infusion
timeFrame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
measure: Percentage of time with a Richmond Agitation-Sedation Sedation Score =0, -1,-2 during the study drug infusion
timeFrame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
measure: Administration frequency and dosage of additional sedatives
timeFrame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
measure: Administration frequency and dosage of additional analgesics
timeFrame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Other outcomes:
Locations:
city: Nishinomiya-City
country: Japan
facility: Hyogo Medical University Hospital
state: Hyogo
city: Kagoshima-City
country: Japan
facility: Kagoshima University Hospital
state: Kagoshima
city: Osakasayama-City
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Suita-City
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Hamamatsu-City
country: Japan
facility: Hamamatsu Medical University Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Sinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Chuo-city
country: Japan
facility: Yamanashi University Hospital
state: Yamanashi
Study officials:
affiliation: Hospira, now a wholly owned subsidiary of Pfizer
name: Misa Kawai
role: STUDY_DIRECTOR
References: