Oxycodone-naloxone in Relieving Opioid-related Constipation
This study has been completed.
Sponsor:
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00412152
First received: December 14, 2006
Last updated: August 9, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Oxycodone nalaxone 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 (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
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. [ Time Frame: 12 weeks with a 6 month open label extension ] [ Designated as safety issue: No ]
| Study Start Date: | January 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
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.
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 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).
Contacts and Locations More Information
Additional Information:
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: | NCT00412152 History of Changes |
| Other Study ID Numbers: | OXN3001, 2005-002398-57 |
| Study First Received: | December 14, 2006 |
| Last Updated: | August 9, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Mundipharma Research GmbH & Co KG:
|
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 |
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 June 17, 2013