Status:
COMPLETED
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
Lead Sponsor:
Sucampo Pharma Americas, LLC
Conditions:
Opioid-Induced Bowel Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
Eligibility Criteria
Inclusion
- Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
- Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
- Willing to continue to abstain from use of disallowed medications as defined per protocol
Exclusion
- Has newly diagnosed impaired renal function identified at the Screening Visit \[i.e., serum creatinine concentration \> 1.8 milligrams per deciliter (mg/dL)\]
- Has experienced an unexplained and/or clinically significant weight loss defined as \> 5% within 90 days prior to Screening Visit.
- Has plans to participate in another trial with an investigational drug or device during the course of the extension study
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
439 Patients enrolled
Trial Details
Trial ID
NCT00620061
Start Date
December 1 2007
End Date
September 1 2009
Last Update
January 21 2020
Active Locations (123)
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1
The Birmingham Pain Center
Birmingham, Alabama, United States, 35242
2
Simon Williamson Clinic, PC
Hueytown, Alabama, United States, 35023
3
Alabama Orthopedic Clinic
Mobile, Alabama, United States, 36608
4
Clinical Research Advantage, Inc./ Mesa Family Medical Center
Mesa, Arizona, United States, 85203