Loperamide Concentrations in Intestinal Failure

High Dose Loperamide in Patients with Intestinal Failure (IF): Plasma Concentration and Electrocardiogram(ECG) Changes - Loperamide Concentrations in IF

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003172-40-GB

Enrollment

Registered

2019-08-15

Start date

2019-11-19

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

Measurement and clarification of plasma loperamide and metabolite concentrations in participants with intestinal failure

Interventions

Trade Name: Imodium Instants Product Name: Imodium Instants Pharmaceutical Form: Tablet INN or Proposed INN: Loperamide CAS Number: 53179-11-6 Other descriptive name: Imodium Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Normal controls and Patients with short small bowels Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 62 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: • Unable to consent • clinically unstable • intolerance/allergy to loperamide • no antibiotics within two weeks • taking any opiate or drugs likely to inhibit/induce relevant cytochrome P450 isoforms or drugs likely to inhibit p-glycoprotein (see background).

Design outcomes

Primary

Measure	Time frame
Main Objective: Study1:To investigate the pharmacokinetics of loperamide in healthy volunteers (n=8) and in patients with SBS-IF with a variety of length of small intestines with or without a colon (n=8 in 3 groups). Study2: To perform a population PK/PD study on loperamide by correlating peak plasma concentrations of loperamide (sampling around Tmax as determined by study 1) and/or salivary concentrations (taken throughout the day) with patient’s (who have SBS-IF) clinical characteristics as potential covariates (NONMEM). We will also correlate plasma concentrations with ECG parameters such as length of QT interval. Such covariate relationships could guide dose optimisation in future patients.;Secondary Objective: N/A;Primary end point(s): Study 1 and 2: The plasma and salivary loperamide and metabolite concentrations.;Timepoint(s) of evaluation of this end point: Study 1 and 2: baseline (0) 30,45,60,90,120,180,240 and 360 post dose. Additional samples will be taken at hourly intervals until 22:00hrs, and then approximately 08:00 12:00, 18:00 22:00hrs for the next two days.	—

Measure

Time frame

Main Objective: Study1:To investigate the pharmacokinetics of loperamide in healthy volunteers (n=8) and in patients with SBS-IF with a variety of length of small intestines with or without a colon (n=8 in 3 groups). Study2: To perform a population PK/PD study on loperamide by correlating peak plasma concentrations of loperamide (sampling around Tmax as determined by study 1) and/or salivary concentrations (taken throughout the day) with patient’s (who have SBS-IF) clinical characteristics as potential covariates (NONMEM). We will also correlate plasma concentrations with ECG parameters such as length of QT interval. Such covariate relationships could guide dose optimisation in future patients.;Secondary Objective: N/A;Primary end point(s): Study 1 and 2: The plasma and salivary loperamide and metabolite concentrations.;Timepoint(s) of evaluation of this end point: Study 1 and 2: baseline (0) 30,45,60,90,120,180,240 and 360 post dose. Additional samples will be taken at hourly intervals until 22:00hrs, and then approximately 08:00 12:00, 18:00 22:00hrs for the next two days.

—

Secondary

Measure	Time frame
Secondary end point(s): Study 1: N/A Study 2: ECG QT interval ;Timepoint(s) of evaluation of this end point: Study 1: N/A Study 2: ECG at baseline	—

Countries

United Kingdom

Contacts

Public ContactDr Stephen Lewis

University Hospitals Plymouth NHS Trust

sjl@doctors.org.uk01752431117

Outcome results

None listed

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