drugset / Trial / NCT02266849

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

NCT02266849

Phase 3 Terminated 12 enrolled Odense University Hospital
RandomizedCrossoverQuadruple-blindTreatment

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Loperamide Small molecule 12 mg