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

Pain Clinical Trial

Official title:

A Randomsied, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of 60-80 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412100
• Other study ID #: OXN3006
• Secondary ID: 2005-003510-15
• Status: Completed
• Phase: Phase 3
• Start date: April 2006
• Est. completion date: September 2008

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Females who are pregnant or lactating.

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

• Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.

Related Conditions & MeSH terms

• Constipation
• Pain

Intervention

Drug:
• Oxycodone naloxone prolonged release tablets (OXN)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research GmbH & Co KG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.		12 weeks with a 6 month open label extension

External Links

•   Results available on website