Oxycodone-Naloxone in Relieving Opioid-Related Constipation - Full Text View

Sponsored by:	Mundipharma Research GmbH & Co KG
Information provided by:	Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:	NCT00412152

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 III

MedlinePlus related topics: Constipation

Drug Information available for: Naloxone Naloxone hydrochloride Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

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.

Study Start Date:	January 2006
Estimated Study Completion Date:	April 2008

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications indexed to this study:

Simpson K, Leyendecker P, Hopp M, Müller-Lissner S, Löwenstein O, De Andrés 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.

Study ID Numbers:	OXN3001, 2005-002398-57
Study First Received:	December 14, 2006
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00412152
Health Authority:	United Kingdom: Research Ethics Committee

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

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Oxycodone

Constipation
Pain
Naloxone

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009