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

NCT ID: NCT02757625

Last Updated: 2018-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-20
• Study Completion Date: 2017-05-24

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DA-9501

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

Group Type: EXPERIMENTAL

Dexmedetomidine hydrochloride

Intervention Type: 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

Interventions

Dexmedetomidine hydrochloride

• 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Subjects aged ≥45 weeks CGA to <17 years old at time of consent. No restriction on sex of subject.

3. [Elective surgical cases] Subjects classified as American Society of Anesthesiologists (ASA) (ASA physical status classification) Class I to III by preoperative diagnosis.

4. [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.

5. [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.

6. If a subject is a female of childbearing potential, she should not be pregnant or possibly pregnant, or lactating.

Exclusion Criteria

1. 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.

2. Subjects with 2nd or 3rd degree heart block during the tests at the screening visit (excluding subjects using a pacemaker).

3. 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

4. Subject of bradycardia (≤10th centile of heart rate for healthy children) during the physical examination at screening period.

5. Subjects with ALT ≥100 U/L during the laboratory tests at the screening visit.

6. 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.

7. Subjects who may need a sedative or analgesic (including narcotics) other than dexmedetomidine, midazolam or fentanyl during treatment with the investigational product.

8. Subjects who have acute febrile illness [with a temperature (core or tympanic) ≥ 38.0°Centigrade] at the screening visit.

9. 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.

10. Subjects who received dexmedetomidine within 48 hours before baseline.

11. Subjects who, in the opinion of the investigator or sub-investigator, may be at increased risk to the subject due to the conduct of the study or may have a disease or factor which will probably preclude the obtainment of sufficient study data.

12. Subjects for whom, in the opinion of the investigator or sub-investigator, risks involved with administration of dexmedetomidine outweigh its benefits (e.g., >2 doses of vasopressor due to cardiogenic shock).

13. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Sponsor's employees directly involved in the conduct of the study.

• Minimum Eligible Age: 45 Weeks
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maruishi Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Hyogo Prefectural Kobe Children's Hospital

Kobe, Hyōgo, Japan

Shikoku Medical Center for Children and Adults

Zentsujichó, Kagawa-ken, Japan

Osaka Women's and Children's Hospital

Izumi, Osaka, Japan

Osaka Medical College Hospital

Takatsuki, Osaka, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Tokyo Metropolitan Children's Medical Center

Fuchū, Tokyo, Japan

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, , Japan

Okayama University Hospital

Okayama, , Japan

Osaka City General Hospital

Osaka, , Japan

Shizuoka Children's Hospital

Shizuoka, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 33813550 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ZIN-DEX-1506&StudyName=Phase+3%2C+Multi-center%2C+Single-arm%2C+Open-label+Study+Evaluating+The+Efficacy%2C+Safety%2C+And+Pharmacokinetics+Of+Da-9501+%28dexmedetomidine+Hydrochloride%29+In+Pediatric+Subjects+In+The+Intensive+Care+Unit

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

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C0801017&StudyName=Phase+3%2C+Multi-center%2C+Single-arm%2C+Open-label+Study+Evaluating+The+Efficacy%2C+Safety%2C+And+Pharmacokinetics+Of+Da-9501+%28dexmedetomidine+Hydrochloride%29+In+Pediatric+Subjects+In+The+Intensive+Care+Unit

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

Other Identifiers

ZIN-DEX-1506

Identifier Type: OTHER

Identifier Source: secondary_id

C0801017

Identifier Type: -

Identifier Source: org_study_id