Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

Last updated: October 19, 2018
Sponsor: Mundipharma Research GmbH & Co KG
Overall Status: Completed

Phase

3

Condition

Pain

Constipation

Treatment

N/A

Clinical Study ID

NCT00412100
OXN3006
2005-003510-15
  • Ages > 18
  • All Genders

Study Summary

The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subjects at least 18 years or older with moderate to severe pain thatrequires around the clock opioid therapy. Subjects must report constipation caused oraggravated by opioids.

Exclusion

Exclusion Criteria:

  • Females who are pregnant or lactating.

  • Subjects with evidence of any clinically unstable disease or subjects with evidence ofimpaired liver/kidney function upon entry into the study.

  • Subjects with evidence of significant structural abnormalities of the gastrointestinaltract.

Study Design

Study Start date:
April 01, 2006
Estimated Completion Date:
September 30, 2008

Study Description

Patients with a documented history of moderate to severe non-malignant pain that require around-the-clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm. The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.