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

This study has been completed.
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
First received: February 11, 2008
Last updated: February 1, 2013
Last verified: February 2013
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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Sucampo Pharma Americas, LLC:

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 for up to 9 months ] [ Designated as safety issue: No ]
  • Frequency of SBMs and BMs [ Time Frame: Monthly for up to 9 months ] [ Designated as safety issue: No ]
  • Responder rates [ Time Frame: Monthly for up to 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    5 point scale used to rate each outcome

  • Mean change from baseline in bowel habit regularity [ Time Frame: Monthly for up to 9 months ] [ Designated as safety issue: No ]
    7 point scale used to rate outcome

Enrollment: 440
Study Start Date: November 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Lubiprostone
24 mcg capsules twice daily (BID) for 9 months
Other Name: Amitiza®


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00620061

  Show 31 Study Locations
Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
  More Information

Responsible Party: Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00620061     History of Changes
Other Study ID Numbers: OBD06S1 
Study First Received: February 11, 2008
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 25, 2016