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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
  Purpose
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.

Condition Intervention Phase
Pain Drug: Oxycodone nalaxone prolonged release tablets (OXN) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Mundipharma Research GmbH & Co KG:

Primary Outcome Measures:
  • 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 ]

Study Start Date: January 2006
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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 to assess the safety and efficacy of oxycodone/naloxone prolonged release compared to oxycodone prolonged-release in relieving opioid-related constipation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412152


Sponsors and Collaborators
Mundipharma Research GmbH & Co KG
Investigators
Principal Investigator: Karen Simpson, MBChB Seacroft Hospital, Pain Management Services, L Ward, York Road, Leeds
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT00412152     History of Changes
Other Study ID Numbers: OXN3001
2005-002398-57 ( EudraCT Number )
First Submitted: December 14, 2006
First Posted: December 15, 2006
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by Mundipharma Research GmbH & Co KG:
A randomised
double blind
parallel group
multicentre study to demonstrate improvement in symptoms of constipation in subjects with non malignant pain
Moderate to severe chronic non-malignant pain

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Oxycodone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists