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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438567
• Other study ID #: OXN3506
• Secondary ID: 2010-021995-27
• Status: Completed
• Phase: Phase 3
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: October 2018
• Source: Mundipharma Research GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Pain

Intervention

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
• oxycodone prolonged release (OxyPR) tablets
Drug: Oxycodone prolonged release tablets Arms: OxyPR Dosage: 2x50mg daily or 2x60mg daily or 2x70mg daily or 2x80mg daily

Locations

Country	Name	City	State
United Kingdom	Ballygomartin Group Practice	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research GmbH & Co KG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 weeks and a 6 month extension
Secondary	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.	5 weeks

External Links

•   Results available on website