Effect of impaired stomach relaxation on reflux

Effect of methylnaltrexone on intragastric pressure, the occurrence of transient lower esophageal sphincter relaxations and reflux events in healthy subjects: a double-blind, placebo-controlled, randomized, cross-over study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000532-17-BE

Enrollment

Registered

2016-02-17

Start date

2016-06-09

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

Impaired gastric accommodation

Interventions

Trade Name: Relistor 12 mg/0,6 ml oplossing voor injectie Product Name: Relistor 12 mg/0,6 ml oplossing voor injectie Pharmaceutical Form: Concentrate for cutaneous solution INN or Proposed INN: METHY

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. History of any upper GI symptoms or GI surgery 2. Psychological disorders 3. Any drug history 4. Use of medication altering GI motility 5. Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of methylnaltrexone on intragastric pressure, the occurrence of transient lower esophageal sphincter relaxations and reflux events in healthy subjects;Secondary Objective: Not applicable;Primary end point(s): To determine the effect of methylnaltrexone on intragastric pressure, the occurrence of transient lower esophageal sphincter relaxations and reflux events;Timepoint(s) of evaluation of this end point: After administration of methylnaltrexone	—

Measure

Time frame

Main Objective: To investigate the effect of methylnaltrexone on intragastric pressure, the occurrence of transient lower esophageal sphincter relaxations and reflux events in healthy subjects;Secondary Objective: Not applicable;Primary end point(s): To determine the effect of methylnaltrexone on intragastric pressure, the occurrence of transient lower esophageal sphincter relaxations and reflux events;Timepoint(s) of evaluation of this end point: After administration of 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

K.U. Leuven

brecht.vanhoutte@kuleuven.be3216330671

Outcome results

None listed

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