Trial | NCT00412152  Report issue

Title

Oxycodone-naloxone in Relieving Opioid-related Constipation
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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Pain

  • Intervention/Treatment

    oxycodone naloxone ...

  • Study Participants

    None
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.
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.
Study Started
Jan 31
2006
Primary Completion
Apr 30
2008
Study Completion
Jun 30
2008
Last Update
Oct 23
2018

Drug Oxycodone nalaxone prolonged release tablets (OXN)

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).
No Results Posted