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

Primary Purpose

Pain, Constipation

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
oxycodone/naloxone prolonged release (OXN PR) tablets
oxycodone prolonged release (OxyPR) tablets
Sponsored by
Mundipharma Research GmbH & Co KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring oxycodone naloxone combination, severe chronic and non-malignant pain, Malignant and non-malignant pain that requires around-the clock opioid therapy, Opioid related constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
  • Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy

Exclusion Criteria

  • Females who are pregnant or lactating.
  • Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
  • Subjects with evidence of impaired liver/kidney function upon entry into the study.

Sites / Locations

  • Ballygomartin Group Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OXN PR tablets

OxyPR tablets

Arm Description

Outcomes

Primary Outcome Measures

Bowel function Index (BFI)
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

Pain Intensity Scale (PIS)
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.

Full Information

First Posted
August 18, 2011
Last Updated
October 19, 2018
Sponsor
Mundipharma Research GmbH & Co KG
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1. Study Identification

Unique Protocol Identification Number
NCT01438567
Brief Title
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
Official Title
A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research GmbH & Co KG

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Constipation
Keywords
oxycodone naloxone combination, severe chronic and non-malignant pain, Malignant and non-malignant pain that requires around-the clock opioid therapy, Opioid related constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OXN PR tablets
Arm Type
Experimental
Arm Title
OxyPR tablets
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
oxycodone/naloxone prolonged release (OXN PR) tablets
Intervention Description
Drug: Oxycodone/naloxone prolonged release tablets Arms: OXN PR Dosage: 2x50/25mg daily or 2x60/30mg daily or 2x70/35mg daily or 2x80/40mg daily
Intervention Type
Drug
Intervention Name(s)
oxycodone prolonged release (OxyPR) tablets
Intervention Description
Drug: Oxycodone prolonged release tablets Arms: OxyPR Dosage: 2x50mg daily or 2x60mg daily or 2x70mg daily or 2x80mg daily
Primary Outcome Measure Information:
Title
Bowel function Index (BFI)
Description
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
Time Frame
5 weeks and a 6 month extension
Secondary Outcome Measure Information:
Title
Pain Intensity Scale (PIS)
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain. Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy Exclusion Criteria Females who are pregnant or lactating. Subjects with evidence or significant structural abnormalities of the gastrointestinal tract. Subjects with evidence of impaired liver/kidney function upon entry into the study.
Facility Information:
Facility Name
Ballygomartin Group Practice
City
Belfast
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=OXN3506
Description
Results available on website

Learn more about this trial

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

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