Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation
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|ClinicalTrials.gov Identifier: NCT00412100|
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : October 23, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Oxycodone naloxone prolonged release tablets (OXN)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||September 2008|
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412100
|Principal Investigator:||Oliver Lowenstein||Private Practice|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Mundipharma Research GmbH & Co KG|
|Other Study ID Numbers:||
|First Posted:||December 15, 2006 Key Record Dates|
|Last Update Posted:||October 23, 2018|
|Last Verified:||October 2018|
parallel-group multicentre study to demonstrate improvement in symptoms of constipation
Moderate to severe, chronic non-malignant pain
Signs and Symptoms, Digestive
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents