The effect of medication to reduce opioid adverse events on oesophageal sensitivity in healthy volunteers.

The effect of naloxone and methylnaltrexone on oesophageal sensitivity in healthy volunteers: a randomized, double-blind placebo controlled study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003409-86-BE

Enrollment

Registered

2012-08-30

Start date

2012-10-09

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

Altered oesophageal sensitivity

Interventions

Trade Name: Naloxon Product Name: Naloxone Pharmaceutical Form: Concentrate for solution for infusion Pharmaceutical form of the placebo: Concentrate for solution for injection/infusion Route of admin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. A history of allergic reaction to naloxon or methylnaltrexone or multiple allergies to several foods and drugs. 2. Pregnancy and/or lactation 3. Concomittant administration of monomine oxidase inhibitors, verapamil, or diltiazem or medications affecting oesophageal motility 4. Significant co-morbidities (neuro-muscular, psychiatric, cardiovascular, pulmonary, endocrine, auto-immune, renal and hepatic)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the acute effect of naloxon and methylnaltrexone administered IV/SC on oesophageal sensitivity in healthy volunteers;Secondary Objective: Not applicable;Primary end point(s): To determine altered oesophageal sensitivity after administration of naloxon or methylnaltrexone vs. placebo;Timepoint(s) of evaluation of this end point: After administration of naloxone or methylnaltrexone	—

Measure

Time frame

Main Objective: To investigate the acute effect of naloxon and methylnaltrexone administered IV/SC on oesophageal sensitivity in healthy volunteers;Secondary Objective: Not applicable;Primary end point(s): To determine altered oesophageal sensitivity after administration of naloxon or methylnaltrexone vs. placebo;Timepoint(s) of evaluation of this end point: After administration of naloxone or methylnaltrexone

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactTARGID

KULeuven

3216341922

Outcome results

None listed

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