ENA-001 for Post Operative Respiratory Depression (PORD)

ConditionRespiratory Depression

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorEnalare Therapeutics Inc.

About this trial

This study is a Phase II, randomized, placebo-controlled, double-blind trial in 200 subjects having general anesthesia for major elective surgery with postoperative pain management to evaluate the efficacy, safety and tolerability of ENA-001 as a therapy to prevent post operative respiratory depression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing to give written informed consent for the trial and willing/able to adhere to study procedures.

Scheduled to undergo a major elective surgery, including abdominal, laparoscopic, nephrology, thoracic (non-cardiac), orthopedic (e.g., shoulder and ankle surgery), where the subject will be transferred to recover in the general postanesthesia recover unit (PACU) and extubation will be performed in the operating room or PACU.

Undergoing surgical procedure with a intraoperative requirement of ≥ 250 µg of fentanyl; Enrolled base on expected pain management to necessitate ≥ 250 µg of fentanyl intraoperatively.

Male and female, ≥18 years of age.

Disqualifiers

Ongoing treatment for a pre-existing chronic pain condition

Use of an epidural / spinal block / major nerve block for the surgical procedure

Surgical procedure that may interfere with the collection of data under the study protocol, such as craniofacial surgery which may impact the placement of a face mask for pulmonary function measurements.

Current diagnosis of psychiatric disease, including anxiety disorder, that is uncontrolled and/or restricting normal daily function.

Trial design

Design model

Parallel

Treatments tested in this trial

ENA-001
Drug
ENA-001 will be prepared in Ringer's lactate solution. A loading dose will be administered for 20 minutes followed by continuous infusion until the patient meets the criteria for PACU discharge (≥ 9 Aldrete score) or ABG reveals PaCO2 \< 30 mmHg with pH in the normal range. ENA-001 is for IV injection ready for use per subject by the investigational pharmacy, according to the randomization schedule.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: ENA-001 Treatment ArmExperimental treatment 1 intervention

Group B: Placebo Treatment ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

To evaluate the effects of ENA-001 on pulmonary ventilation when administered to 100 subjects via continuous infusion of a loading dose of 2.0 mg/kg/hr for 20 minutes followed by a maintenance dose of 1.1 mg/kg/hr

To evaluate the effect of ENA-001 on pulmonary ventilation following extubation/airway removal up to two hours beyond cessation of treatment. Endpoint is arterial CO2 tension (PaCO2)

Time frame

2 hours

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Enalare Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: