Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
This study has been completed.
Sponsor:
Cubist Pharmaceuticals
Collaborator:
GlaxoSmithKline
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00256932
First received: November 21, 2005
Last updated: March 6, 2009
Last verified: March 2009
Tracking Information | |||||
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First Received Date ICMJE | November 21, 2005 | ||||
Last Updated Date | March 6, 2009 | ||||
Start Date ICMJE | August 2005 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
to compare alvimopan with placebo for efficacy in the treatment of OBD | ||||
Original Primary Outcome Measures ICMJE |
to compare alvimopan with placebo for efficacy in the treatment of OBD | ||||
Change History | Complete list of historical versions of study NCT00256932 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Safety and tolerability, quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data) | ||||
Original Secondary Outcome Measures ICMJE |
Safety and tolerability, quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data) | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain | ||||
Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain | ||||
Brief Summary | Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: alvimopan
Other Name: alvimopan |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 480 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Austria, Canada, Denmark, Estonia, Finland, Germany, Ireland, Poland, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00256932 | ||||
Other Study ID Numbers ICMJE | SB-767905/012 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Study Director, GSK | ||||
Study Sponsor ICMJE | Cubist Pharmaceuticals | ||||
Collaborators ICMJE | GlaxoSmithKline | ||||
Investigators ICMJE |
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Information Provided By | Cubist Pharmaceuticals | ||||
Verification Date | March 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |