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Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00412100
First received: December 14, 2006
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  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 3

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
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. [ Time Frame: 12 weeks with a 6 month open label extension ] [ Designated as safety issue: No ]

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:
Results available on website  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):

Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT00412100     History of Changes
Other Study ID Numbers: OXN3006, 2005-003510-15
Study First Received: December 14, 2006
Last Updated: August 9, 2012
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 May 23, 2013