Oxycodone-naloxone in Relieving Opioid-related Constipation

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ClinicalTrials.gov Identifier: NCT00412152

Recruitment Status : Completed

First Posted : December 15, 2006

Last Update Posted : October 23, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Mundipharma Research GmbH & Co KG

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pain	Drug: Oxycodone nalaxone prolonged release tablets (OXN)	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
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.
Study Start Date :	January 2006
Actual Primary Completion Date :	April 2008
Actual Study Completion Date :	June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Drug Information available for: Oxycodone Oxycodone hydrochloride

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

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Principal Investigator:	Karen Simpson, MBChB	Seacroft Hospital, Pain Management Services, L Ward, York Road, Leeds

More Information

Additional Information:

Results available on website This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lowenstein O, Leyendecker P, Lux EA, Blagden M, Simpson KH, Hopp M, Bosse B, Reimer K. Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials. BMC Clin Pharmacol. 2010 Sep 29;10:12. doi: 10.1186/1472-6904-10-12.

Simpson K, Leyendecker P, Hopp M, Muller-Lissner S, Lowenstein O, De Andres J, Troy Ferrarons J, Bosse B, Krain B, Nichols T, Kremers W, Reimer K. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin. 2008 Dec;24(12):3503-12. doi: 10.1185/03007990802584454.

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Responsible Party:	Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:	NCT00412152
Other Study ID Numbers:	OXN3001 2005-002398-57 ( EudraCT Number )
First Posted:	December 15, 2006 Key Record Dates
Last Update Posted:	October 23, 2018
Last Verified:	October 2018

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:

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Constipation Signs and Symptoms, Digestive Oxycodone Analgesics, Opioid Narcotics	Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents

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