Reversal through hypothalamus hormone of breting compromise from opioids

Reversal through TRH of opioid-induced respiratory depression (OIRD) in healthy volunteers - RETRO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004973-15-NL

Enrollment

Registered

2018-03-07

Start date

2018-04-09

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

opioid-induced respiratory depression MedDRA version: 20.0 Level: PT Classification code 10038678 Term: Respiratory depression System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10038680 Term: Respiratory depression postoper System Organ Class: 10038738 - R

Interventions

Trade Name: Protirelin Product Name: Protirelin Product Code: PL 1685/0115 Pharmaceutical Form: Injection Pharmaceutical form of the pla

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Healthy male or female volunteers; - Age: 18 - 40 years; - Body mass index =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Known or suspected neuromuscular or a (family) history of any neuromuscular disease; - A history of allergic reaction to food or medication including study medication; - Any current or previous medical (including high blood pressure), neurological or psychiatric illness (including a history of anxiety); - Alcohol abuse (> 21 units/week); - Known or suspected neuromuscular or a (family) history of any neuromuscular disease; - A history of allergic reaction to food or medication including study medication; - Any current or previous medical (including high blood pressure), neurological or psychiatric illness (including a history of anxiety); - Alcohol abuse (> 21 units/week); - Illicit drug use in the past 30 days before inclusion; - Pregnancy or lactation; - Participation in any medical or drug trial in the month prior to the current study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the ability of TRH to reverse opioid-induced respiratory depression ;Secondary Objective: Not applicable;Primary end point(s): Ventilation increase following opioid-induced respiratory depression; Timepoint(s) of evaluation of this end point: Time points = 60 min period of TRH infusion and 6 h measurement following taltirelin treatment	—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: none	—

Countries

Netherlands

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center

a.dahan@lumc.nl715262301

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026