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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT01438567
First received: August 18, 2011
Last updated: October 13, 2014
Last verified: January 2014

August 18, 2011
October 13, 2014
September 2011
February 2014   (final data collection date for primary outcome measure)
Bowel function Index (BFI) [ Time Frame: 5 weeks and a 6 month extension ] [ Designated as safety issue: No ]
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
Bowel function Index (BFI) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01438567 on ClinicalTrials.gov Archive Site
Pain Intensity Scale (PIS) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
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

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Pain
  • Constipation
  • Drug: oxycodone/naloxone prolonged release (OXN PR) tablets
    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
  • Drug: oxycodone prolonged release (OxyPR) tablets
    Drug: Oxycodone prolonged release tablets Arms: OxyPR Dosage: 2x50mg daily or 2x60mg daily or 2x70mg daily or 2x80mg daily
  • Experimental: OXN PR tablets
    Intervention: Drug: oxycodone/naloxone prolonged release (OXN PR) tablets
  • Active Comparator: OxyPR tablets
    Intervention: Drug: oxycodone prolonged release (OxyPR) tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
September 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01438567
OXN3506, 2010-021995-27
Not Provided
Mundipharma Research GmbH & Co KG
Mundipharma Research GmbH & Co KG
Not Provided
Not Provided
Mundipharma Research GmbH & Co KG
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP