Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit

NCT02757625 | Completed Phase 3 Results DMC

• 2 other identifiers: C0801017ZIN-DEX-1506
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 12

Brief Summary

To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects \[≥ 45 weeks CGA (corrected gestational age) to \<17 years old\] requiring sedation under intensive care unit

Conditions

ICU Sedation

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug

  Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation \[placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs\], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation \[removal of endotracheal tube\], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.

  From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Secondary Outcomes (22)

• Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug

  From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

• Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug

  From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

• Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug

  From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

• Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug

  From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

• Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug

  From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Other Outcomes (6)

• Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE)

  Baseline up to 28 days after end of study drug dosing (up to 56 days)

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  Baseline up to 28 days after end of study drug dosing (Day 56)

• Number of Participants With Laboratory Test Abnormalities

  Baseline up to 28 days after end of study drug dosing (Day 56)

Study Arms (1)

DA-9501

EXPERIMENTAL

A single vial contains an injection solution with 2 mL of dexmedetomidine hydrochloride solution (100 µg/mL as dexmedetomidine) dissolved in physiological saline

Drug: Dexmedetomidine hydrochloride

Interventions

Dexmedetomidine hydrochloride DRUG

* 45 weeks CGA to \< 6 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.4 µg/kg/h according to the pediatric subject's sedative state * 6 years old to \< 17 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.0 µg/kg/h according to the pediatric subject's sedative state

DA-9501

Eligibility Criteria

• Age: 45 Weeks - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects whose consent is obtained in writing prior to the clinical trial from a guardian after a full explanation. For subjects over 7 years old, it is desirable that an informed assent is also obtained from the pediatric subject him/herself when possible.
• Subjects aged ≥45 weeks CGA to \<17 years old at time of consent. No restriction on sex of subject.
• \[Elective surgical cases\] Subjects classified as American Society of Anesthesiologists (ASA) (ASA physical status classification) Class I to III by preoperative diagnosis.
• \[Elective surgical cases\] Subjects who require at least 6 hours of respiratory management with intubation under intensive care from immediately after surgery and are anticipated to require sedation.
• \[Medical ICU cases\] Subjects who require at least 24 hours of respiratory management with intubation under intensive care and are anticipated to require sedation. For medical ICU cases, sedatives used prior to treatment with the investigational product should be discontinued before the start of treatment with the investigational product.
• If a subject is a female of childbearing potential, she should not be pregnant or possibly pregnant, or lactating.

You may not qualify if:

• Subjects who are judged by investigator or sub-investigator to have a neurological disease that will make sedation assessment difficult, such as:
• Subjects with brain damage which is expected to increase intracranial pressure due to trauma or central nervous system disease
• Subjects with cerebral palsy, autism, severe mental retardation, etc.
• Subjects with paralysis due to continuous administration of a muscle relaxant or due to a spinal injury of class T5 or higher.
• Subjects with 2nd or 3rd degree heart block during the tests at the screening visit (excluding subjects using a pacemaker).
• Subjects with any of the following low blood pressure levels during the tests at the screening visit:
• Age ≥ 45 weeks CGA to \< 1 year old: Systolic Blood Pressure (SBP) \<70 mmHg
• Age ≥ 1 year old to \< 10 years old: SBP \< 70 + (2 x age in years) mmHg
• Age ≥ 10 years old to \< 17 years old: SBP \< 90 mmHg
• Subject of bradycardia (≤10th centile of heart rate for healthy children) during the physical examination at screening period.
• Subjects with ALT ≥100 U/L during the laboratory tests at the screening visit.
• Subjects in whom dexmedetomidine or other alfa 2 receptor agonists, alfa 2 receptor antagonists and drug that may be used in this study are contraindicated.
• Subjects who may need a sedative or analgesic (including narcotics) other than dexmedetomidine, midazolam or fentanyl during treatment with the investigational product.
• Subjects who have acute febrile illness \[with a temperature (core or tympanic) ≥ 38.0°Centigrade\] at the screening visit.
• Subjects who received other investigational product within 30 days before baseline or subjects who will participate in other study that uses an investigational product during the study period.

Sponsors & Collaborators

• Pfizer: lead
• Maruishi Pharmaceutical: collaborator

Study Sites (12)

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, 078-8510, Japan

Location

Hyogo Prefectural Kobe Children's Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Shikoku Medical Center for Children and Adults

Zentsujichó, Kagawa-ken, 765-8507, Japan

Location

Osaka Women's and Children's Hospital

Izumi, Osaka, 594-1101, Japan

Location

Osaka Medical College Hospital

Takatsuki, Osaka, 569-8686, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Tokyo Metropolitan Children's Medical Center

Fuchū, Tokyo, 183-8561, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

Shizuoka Children's Hospital

Shizuoka, 420-8660, Japan

Location

Related Publications (1)

• Takeuchi M, Nemoto S, Suzuki Y, Takahashi N, Takenaka N, Takata A, Kobayashi M. Age-Specific Dose Regimens of Dexmedetomidine for Pediatric Patients in Intensive Care Following Elective Surgery: A Phase 3, Multicenter, Open-Label Clinical Trial in Japan. Pediatr Crit Care Med. 2021 Nov 1;22(11):e546-e557. doi: 10.1097/PCC.0000000000002730.

  PMID: 33813550 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: April 11, 2016
• First Posted: May 2, 2016
• Study Start: July 20, 2016
• Primary Completion: May 24, 2017
• Study Completion: May 24, 2017
• Last Updated: December 17, 2018
• Results First Posted: December 17, 2018

Record last verified: 2018-05

Locations

JP (12)