Back to resultsOxycodone-naloxone in Relieving Opioid-related Constipation
Primary Purpose
Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Oxycodone nalaxone prolonged release tablets (OXN)
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring A randomised, double blind, parallel group, multicentre study to demonstrate improvement in symptoms of constipation in subjects with non malignant pain, Moderate to severe chronic non-malignant pain
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).
Sites / Locations
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00412152
First Posted
December 14, 2006
Last Updated
October 19, 2018
Sponsor
Mundipharma Research GmbH & Co KG
1. Study Identification
Unique Protocol Identification Number
NCT00412152
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research GmbH & Co KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
A randomised, double blind, parallel group, multicentre study to demonstrate improvement in symptoms of constipation in subjects with non malignant pain, Moderate to severe chronic non-malignant pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxycodone nalaxone prolonged release tablets (OXN)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Simpson, MBChB
Organizational Affiliation
Seacroft Hospital, Pain Management Services, L Ward, York Road, Leeds
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20920236
Citation
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.
Results Reference
derived
PubMed Identifier
19032132
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=OXN3001
Description
Results available on website
Learn more about this trial
Oxycodone-naloxone in Relieving Opioid-related Constipation
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