NCT01915147

A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Mundipharma Research GmbH & Co KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is intended to explore changes in the composition and quantity of gut bacteria subject to treatment with strong pain medication. Two pain medications will be compared (OXN PR and OxyPR). Other gastrointestinal parameters will be assessed.

Detailed description

Patients who require around-the-clock opioid therapy and show symptoms of constipation secondary to opioid treatment will be randomised to receive either OXN PR followed by OxyPR, or vice versa. Each treatment takes 24days. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and a Follow-up phase.

Conditions

• Severe Chronic Pain

Interventions

Type	Name	Description
DRUG	OXN PR followed by OxyPR tablets
DRUG	OxyPR followed by OXN PR tablets

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-02-01
• Completion: 2015-09-01
• First posted: 2013-08-02
• Last updated: 2015-12-14

Locations

2 sites across 1 country: Germany