Oxycodone-Naloxone Prolonged Release Tablets 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:	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

MedlinePlus related topics: Constipation

Drug Information available for: Oxycodone Oxycodone hydrochloride Naloxone hydrochloride Naloxone

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

No publications provided

Study ID Numbers:	2005-003510-15, OXN3006
Study First Received:	December 14, 2006
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00412100 History of Changes
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
Narcotic Antagonists
Oxycodone
Constipation
Central Nervous System Depressants

Narcotics
Pain
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid
Naloxone

Additional relevant MeSH terms:

Signs and Symptoms, Digestive
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Naloxone

Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Constipation
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009