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Naloxone SR Capsules in Patients With Opioid Induced Constipation

NCT00984334 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-12-27

Study results available
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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.

Conditions

Interventions

DRUG

Naloxone SR 5 mg capsules

DRUG

Placebo

DRUG

Naloxone SR 10 mg capsules

DRUG

Naloxone SR 20mg capsules

DRUG

Naloxone SR 2.5 mg capsules

Sponsors & Collaborators

  • S.L.A. Pharma AG

    lead INDUSTRY

Principal Investigators

  • Karen Simpson, MD · St James University Hospital, Leeds, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-01-31
Completion
2012-04-30

Countries

  • Germany
  • United Kingdom

Study Locations

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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 NCT00984334 on ClinicalTrials.gov