Oxycodone-Naloxone Prolonged Release Tablets 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 naloxone 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):
Oliver Lowenstein, Principal Investigator, Affiliation: Private Practice
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 release tablets alone.
Clinical Details
Official title: A Randomsied, Double-Blind, Double-Dummy, Parallel-Group Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-Malignant Pain Taking Oxycodone Equivalent of 60-80 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 alone.
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 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 release tablets alone.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: April 2006
Ending date: July 2008
Last updated: April 29, 2008
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