Status:
COMPLETED
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
Lead Sponsor:
Mundipharma Research GmbH & Co KG
Conditions:
Pain
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 OxyP...
Detailed Description
The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT01438567
Start Date
September 1 2011
End Date
September 1 2014
Last Update
October 23 2018
Active Locations (1)
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1
Ballygomartin Group Practice
Belfast, United Kingdom