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

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
NCT00620061
First received: February 11, 2008
Last updated: February 1, 2013
Last verified: February 2013
  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 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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Sucampo Pharma Americas, LLC ( 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:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014