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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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).

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

Details

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

Criteria

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.