Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation
CompletedPhase 3NCT00412100
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study 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
- Conditions
- Interventions
- Drug: Oxycodone naloxone prolonged release tablets (OXN)
- Sponsor
- Mundipharma Research GmbH & Co KG
- Start date
- 2006-04
- Primary completion
- 2008-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00412100