Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-27

Study Completion Date

2025-05-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children

NCT02533908

Inhalation of Nitrous Oxide Opioid Analgesic Adverse Reaction Pain

COMPLETED PHASE3

Topical Anesthetic for Procedures Through the Nose

NCT02667054

Drug Reaction to Analgesic Nos

COMPLETED PHASE3

Pain Free Laceration Repairs Using Intra-nasal Ketamine

NCT03053947

Laceration

COMPLETED PHASE2

IN Ketamine Vs IN Midazolam and Fentanyl for Abscess I&D

NCT02635282

Abscess Pain

COMPLETED PHASE4

Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children

NCT02653742

Pain, Postoperative Otitis Media

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CT001

Group Type EXPERIMENTAL

CT001

Intervention Type DRUG

Intranasal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT001

Intranasal

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pediatric participant, age 1 year to 17 years
* Attending an Emergency Department following an injury
* Acute pain of moderate or severe intensity
* Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)

Exclusion Criteria

* Participant showing abnormal nasal cavity/airway such as:

1. major septal deviation
2. evidence of previous nasal disease or surgery
3. current significant nasal congestion due to common cold
* Has received treatment with sufentanil and/or ketamine during the last 72 hours
* Known or suspected allergy to ketamine or sufentanil
* Critical, life- or limb-threatening condition requiring immediate management

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No