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Oxycodone-naloxone in Relieving Opioid-related Constipation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00412152
First Posted: December 15, 2006
Last Update Posted: August 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
December 14, 2006
December 15, 2006
August 10, 2012
January 2006
April 2008   (Final data collection date for primary outcome measure)
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. [ Time Frame: 12 weeks with a 6 month open label extension ]
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.
Complete list of historical versions of study NCT00412152 on ClinicalTrials.gov Archive Site
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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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
Drug: Oxycodone nalaxone prolonged release tablets (OXN)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2008
April 2008   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United Kingdom
 
NCT00412152
OXN3001
2005-002398-57 ( EudraCT Number )
No
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Mundipharma Research GmbH & Co KG
Mundipharma Research GmbH & Co KG
Not Provided
Principal Investigator: Karen Simpson, MBChB Seacroft Hospital, Pain Management Services, L Ward, York Road, Leeds
Mundipharma Research GmbH & Co KG
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP