A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy

Phase 3

Completed

• Conditions: Constipation; Pain
• Interventions: Drug: oxycodone prolonged release (OxyPR) tablets; Drug: oxycodone/naloxone prolonged release (OXN PR) tablets

• Registration Number: NCT01438567
• Lead Sponsor: Mundipharma Research GmbH & Co KG

Brief Summary

The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).

Detailed Description

The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.

Study Timeline

• Study First Submitted: 2011-08-18
• Study Start: 2011-09
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Primary Completion: 2014-02
• Study Completion: 2014-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OxyPR tablets	oxycodone prolonged release (OxyPR) tablets	-
OXN PR tablets	oxycodone/naloxone prolonged release (OXN PR) tablets	-

Primary Outcome Measures

Name	Time	Method
Bowel function Index (BFI)	5 weeks and a 6 month extension	To demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR

Secondary Outcome Measures

Name	Time	Method
Pain Intensity Scale (PIS)	5 weeks	To demonstrate non-inferiority of OXN PR compared to OxyPR with respect to the analgesic efficacy based on the subjects' 'Average Pain over last 24 Hours' assessed at each Double-blind Phase visit as measured by the Pain Intensity Scale.

Trial Locations

Locations (1)

Ballygomartin Group Practice; 🇬🇧 Belfast, United Kingdom