Status:
COMPLETED
Oxycodone-naloxone 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 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 const...
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 to as...
Eligibility Criteria
Inclusion
- Male or female subjects at lest 18 years or older with pain.
- Subjects must report constipation caused or aggravated by opioids.
Exclusion
- Females who are pregnant or lactating.
- Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract (e.g. bowel obstruction, strictures).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
June 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00412152
Start Date
January 1 2006
End Date
June 1 2008
Last Update
October 23 2018
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