drugset / Trial / NCT01596764

Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.

NCT01596764

Phase 1 Completed 16 enrolled University Medicine Greifswald
RandomizedCrossoverTriple-blindBasic science

Summary

The purpose of this study is to describe the effects of repeated-dose methylnaltrexone in preventing loperamide-induced delay of whole-gut, oro-cecal and colon transit time and to measure pharmacokinetics of methylnaltrexone and naloxone-3-glucuronide after oral administration of methylnaltrexone and naloxone.

Timeline

Start
2011-05
Primary completion
2011-07
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylnaltrexone Other / unclassified 150 mg Oral
Comparator Naloxone Small molecule 20 mg Oral
Comparator Loperamide Small molecule 4 mg
Comparator Sulfasalazine Small molecule 500 mg