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

NCT00526760 | Completed Phase 3

• 1 other identifier: DEX-402
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Sedation

Keywords

Dexmedetomidine, Sedation, Long-term, Phase 3

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 American Society of Anesthesiologists (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.

You may not qualify if:

• Patient has serious central nervous system (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.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead
• Maruishi Pharmaceutical: collaborator

Study Sites (10)

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Kinki University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Hamamatsu Medical University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Jikei University Hospital

Minato-ku, Tokyo, 105-8741, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Keio University Hospital

Sinjuku-ku, Tokyo, 160-8582, Japan

Location

Yamanashi University Hospital

Chūō, Yamanashi, 409-3898, Japan

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Misa Kawai

  Hospira, now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2007
• First Posted: September 10, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

JP (10)