Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation - Full Text View

Sponsor:	Mundipharma Research GmbH & Co KG
Information provided by:	Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:	NCT00412100

Purpose

The primary objective is to demonstrate that patients 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 naloxone prolonged release tablets (OXN)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomsied, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of 60-80 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: Oxycodone Oxycodone hydrochloride Naloxone hydrochloride Naloxone

U.S. FDA Resources

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 alone.

Study Start Date:	April 2006
Study Completion Date:	September 2008
Primary Completion Date:	July 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. The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

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 least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. Subjects must report constipation caused or aggravated by opioids.

Exclusion Criteria:

Females who are pregnant or lactating.
Subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study.
Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412100

Sponsors and Collaborators

Mundipharma Research GmbH & Co KG

Investigators

Principal Investigator:

Oliver Lowenstein

Private Practice

More Information

Additional Information:

Click here fore more information This link exits the ClinicalTrials.gov site

No publications provided by Mundipharma Research GmbH & Co KG

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

Löwenstein 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.

ClinicalTrials.gov Identifier:	NCT00412100 History of Changes
Other Study ID Numbers:	OXN3006, 2005-003510-15
Study First Received:	December 14, 2006
Last Updated:	February 7, 2011
Health Authority:	Germany: Ethics Commission

Keywords provided by Mundipharma Research GmbH & Co KG:

A randomised
double-blind
double-dummy
parallel-group multicentre study to demonstrate improvement in symptoms of constipation
Moderate to severe, chronic non-malignant pain

Additional relevant MeSH terms:

Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Naloxone
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 12, 2012