drugset / Trial / NCT00984334

Naloxone SR Capsules in Patients With Opioid Induced Constipation

NCT00984334

Phase 2 Completed 40 enrolled S.L.A. Pharma AG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

For many patients taking opioids for pain relief one of the most distressing side effects is constipation. Naloxone is effective in the reversal of the effects of opioids and is used following opioid overdose. If naloxone is given by mouth it would relieve the effects of constipation but as it goes into the blood stream very quickly, it would also reverse the effects of the opioid and therefore stop the pain relief. The aim of this study is to examine a slow release formulation of naloxone to see if is can reduce constipation without reducing the pain relieving effects of the opioid.

Timeline

Start
2009-10
Primary completion
2012-01
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 2.5 mg Oral
Subject Naloxone Small molecule 5 mg Oral
Subject Naloxone Small molecule 10 mg Oral
Subject Naloxone Small molecule 20 mg Oral