Oxycodone-naloxone in Relieving Opioid-related Constipation

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Research GmbH & Co KG
• Treatments: Naloxone; Oxycodone

Criteria

Inclusion Criteria:

• Male or female subjects at lest 18 years or older with pain.

• Subjects must report constipation caused or aggravated by opioids.

Exclusion Criteria:

• Females who are pregnant or lactating.

• Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract (e.g. bowel obstruction, strictures).