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Oxycodone-naloxone in Relieving Opioid-related Constipation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00412152
First received: December 14, 2006
Last updated: August 9, 2012
Last verified: August 2012

December 14, 2006
August 9, 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00412152
OXN3001, 2005-002398-57
No
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