MedTrace Logo

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study

NCT02266849 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-10-11

No results posted yet for this study

Summary

Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo.

Loperamide will be evaluated in relation to the following parameters

* Change in ileostomy output in g/day in relation to oral intake
* Quantification of the change in intestinal transit time using a radiopaque marker
* The patient´s own assessment on which period they received Loperamide or Placebo

Conditions

Interventions

DRUG

Loperamide

12 mg Loperamide each day for three days

DRUG

Placebo

6 tablets daily for three days

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Niels Qvist, MD, DMsc · Odense University Hospital, Department of Surgery A, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266849 on ClinicalTrials.gov