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

Phase 1

• Conditions: Altered oesophageal sensitivity; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2012-003409-86-BE
• Lead Sponsor: KULeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-30
• Study Completion: 2014-12-18
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Age >18 and <60 years
2. No history of GI disorders or symptoms
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified