Status:
COMPLETED
Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation
Lead Sponsor:
Mundipharma Research GmbH & Co KG
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 r...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00412100
Start Date
April 1 2006
End Date
September 1 2008
Last Update
October 23 2018
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