Oxycodone-Naloxone Prolonged Release Tablets in Relieving Opioid-Related Constipation - Full Text View

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

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 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

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
Estimated Study Completion Date:	July 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. 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

Study ID Numbers:	2005-003510-15, OXN3006
First Received:	December 14, 2006
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00412100
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

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

Narcotic Antagonists

Central Nervous System Depressants

Narcotics

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Analgesics, Opioid

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

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