Oxycodone-naloxone in Relieving Opioid-related Constipation
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.
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2006
Typical duration for phase_3 pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 14, 2006
CompletedFirst Posted
Study publicly available on registry
December 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedOctober 23, 2018
October 1, 2018
2.2 years
December 14, 2006
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks with a 6 month open label extension
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects at lest 18 years or older with pain.
- Subjects must report constipation caused or aggravated by opioids.
You may not qualify if:
- Females who are pregnant or lactating.
- Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract (e.g. bowel obstruction, strictures).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 20920236DERIVEDSimpson 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.
PMID: 19032132DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Simpson, MBChB
Seacroft Hospital, Pain Management Services, L Ward, York Road, Leeds
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2006
First Posted
December 15, 2006
Study Start
January 1, 2006
Primary Completion
April 1, 2008
Study Completion
June 1, 2008
Last Updated
October 23, 2018
Record last verified: 2018-10