Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620061
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )

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

Condition or disease Intervention/treatment Phase
Opioid-Induced Bowel Dysfunction Drug: Lubiprostone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction
Study Start Date : November 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Lubiprostone
24 mcg capsules twice daily (BID) for 9 months
Other Name: Amitiza®

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change from baseline in spontaneous bowel movement (SBM) and bowel movement (BM) frequency [ Time Frame: Monthly for up to 9 months ]
  2. Frequency of SBMs and BMs [ Time Frame: Monthly for up to 9 months ]
  3. Responder rates [ Time Frame: Monthly for up to 9 months ]
  4. Mean change from baseline in straining associated with SBMs; stool consistency of SBMs; constipation severity; treatment effectiveness; abdominal bloating; and abdominal discomfort. [ Time Frame: Monthly for up to 9 months ]
    5 point scale used to rate each outcome

  5. Mean change from baseline in bowel habit regularity [ Time Frame: Monthly for up to 9 months ]
    7 point scale used to rate outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00620061

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Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.

Responsible Party: Sucampo Pharmaceuticals, Inc. Identifier: NCT00620061     History of Changes
Other Study ID Numbers: OBD06S1
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action