Oxycodone-Naloxone in Relieving Opioid-Related Constipation
Information source: Mundipharma Research GmbH & Co KG
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Oxycodone nalaxone prolonged release tablets (OXN) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Mundipharma Research GmbH & Co KG Official(s) and/or principal investigator(s):
Karen Simpson, MBChB, Principal Investigator, Affiliation: Seacroft Hospital, Pain Management Services, L Ward, York Road, Leeds
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 constipation compared to subjects taking oxycodone prolonged release tablets
alone.
Clinical Details
Official title: A Randomised, Double-Blind, Parallel-Group, Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-Malignant Pain Taking Oxycodone Equivalent of >20 mg/Day and <50 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets.
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 assess the safety and efficacy of oxycodone/naloxone prolonged release
compared to oxycodone prolonged-release in relieving opioid-related constipation.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female subjects at lest 18 years or older with pain.
- Subjects must report constipation caused or aggravated by opioids.
Exclusion Criteria:
- Females who are pregnant or lactating.
- Subjects with evidence of significant structural abnormalities of the gastrointestinal
(GI) tract (e. g. bowel obstruction, strictures).
Locations and Contacts
Additional Information
Starting date: January 2006
Ending date: April 2008
Last updated: April 29, 2008
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