Oxycodone-naloxone in Relieving Opioid-related Constipation

• ClinicalTrials.gov Identifier: NCT00412152
• Recruitment Status: Completed
• First Posted: December 15, 2006
• Last Update Posted: October 23, 2018
• Sponsor: Mundipharma Research GmbH & Co KG
• Information provided by (Responsible Party): Mundipharma Research GmbH & Co KG

Tracking Information

• First Submitted Date: December 14, 2006
• First Posted Date: December 15, 2006
• Last Update Posted Date: October 23, 2018
• Study Start Date: January 2006
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 17, 2012): 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. [ Time Frame: 12 weeks with a 6 month open label extension ]
• Original Primary Outcome Measures (submitted: December 14, 2006): 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.
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oxycodone-naloxone in Relieving Opioid-related Constipation
• 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.
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain
• Intervention: Drug: Oxycodone nalaxone prolonged release tablets (OXN)
• Study Arms: Not Provided

Publications *

• Lowenstein 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. doi: 10.1186/1472-6904-10-12.
• Simpson K, Leyendecker P, Hopp M, Muller-Lissner S, Lowenstein O, De Andres 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. doi: 10.1185/03007990802584454.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00412152
• Other Study ID Numbers: OXN3001; 2005-002398-57 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mundipharma Research GmbH & Co KG
• Original Responsible Party: Not Provided
• Current Study Sponsor: Mundipharma Research GmbH & Co KG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Karen Simpson, MBChB; Seacroft Hospital, Pain Management Services, L Ward, York Road, Leeds

• PRS Account: Mundipharma Research GmbH & Co KG
• Verification Date: October 2018