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Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation

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ClinicalTrials.gov Identifier: NCT01460225
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : February 27, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: lubiprostone Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation
Study Start Date : September 2007
Primary Completion Date : December 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: lubiprostone
    24 micrograms twice daily for 1 week

Outcome Measures

Primary Outcome Measures :
  1. evaluation of gastric emptying [ Time Frame: 1 week ]

Eligibility Criteria

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:

  • chronic idiopathic constipation

Exclusion Criteria:

  • medications that slow gastrointestinal (GI) motility
  • prior surgery to the GI tract
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01460225

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Takeda Pharmaceuticals North America, Inc.
More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460225     History of Changes
Other Study ID Numbers: 07-033L
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012

Keywords provided by Dartmouth-Hitchcock Medical Center:
chronic idiopathic constipation
no prior history of surgery to the colon
not on any type of medication that could alter gastrointestinal motility or transit

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action