Opioid-Induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone - Full Text View

Sponsors and Collaborators:	Sucampo Pharmaceuticals, Inc. Takeda Pharmaceutical Company Limited
Information provided by:	Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00620061

Purpose

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in patients with OBD.

Condition	Intervention	Phase
Opioid-Induced Bowel Dysfunction	Drug: Lubiprostone	Phase III

Drug Information available for: Lubiprostone

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Open-Labeled Study of the Long-Term Safety and Efficacy of Lubiprostone in Patients With Opioid-Induced Bowel Dysfunction

Further study details as provided by Sucampo Pharmaceuticals, Inc.:

Primary Outcome Measures:

Evaluation of overall safety, including AEs; clinical laboratory evaluations; vital signs; 12-lead resting electrocardiograms; and physical examination results. [ Time Frame: Across 9-month treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in spontaneous bowel movement (SBM) and bowel movement (BM) frequency [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Frequency of SBMs and BMs [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Responder rates [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Mean change from baseline in straining associated with SBMs; stool consistency of SBMs; constipation severity; treatment effectiveness; abdominal bloating; abdominal discomfort; and bowel habit regularity. [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Estimated Enrollment:	440
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lubiprostone 24 mcg capsules twice daily (BID) for 9 months

Eligibility

Criteria

Inclusion Criteria:

Patient has completed 12 weeks of blinded treatment in the SPI/0211OBD-0631 or SPI/0211OBD-0632 study.
Patient 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.
Patient must be willing to continue to abstain from use of disallowed medications as defined per protocol.

Exclusion Criteria:

Patient has newly diagnosed impaired renal function identified at the Screening Visit (i.e., serum creatinine concentration > 1.8 mg/dL).
Patient has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit.
Patient plans to participate in another trial with an investigational drug or device during the course of the extension study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620061

Contacts

Contact: OPAL Study

Sponsors and Collaborators

Sucampo Pharmaceuticals, Inc.

Takeda Pharmaceutical Company Limited

More Information

Responsible Party:	Sucampo Pharmaceuticals, Inc. ( Clinical Trial Manager )
Study ID Numbers:	OBD06S1
Study First Received:	February 11, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00620061
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 16, 2009